Pfizer

Employee received the vaccine around 1130. She was monitored for a least 30 minutes due to her history of CA and Immunosupressed state. She went back to her office post monitoring. Around 1535, one of her employees called reporting that she didn't look good and was acting weird - pale; stumbling; slurred speech. The coworker brought employee to the immunization clinic in private vehicle. Dr. along with the CNE and another RN went to the vehicle to asses. It was noted that employee did have slurred/slow speech; droopiness to face. She reported that she started to not feel well while in her office. V/S: B/P 141/102; pulse 108; O2 sat 96% on RA; skin pale. She stated that she felt "loopy". Employees husband was called and her co-worker was instructed to take the employee to the ER where her husband would meet them. At 1540, employee was taken to ER for evaluation.

Rec'd Covid vaccine after 15 min obs stated she felt "swooney, dizzy, like" BP 168/86 HR 68 states she has a hx of HTN she usually runs 120's/70's Monitored for another 25 min BP ranging 157/87 - 173/86, prior to leaving states she was not feeling dizzy anymore BP 164/88 HR 69, and wanted to go back to work. Could not find anyone to take care of her patients and was concerned. Coworker states they would monitor her.

19th received Covid Vaccine at noon 21st negative Covid surveillance test completed due to ED Cluster 22nd Bedtime approx. 2100 A very strange feeling of overwhelming fatigue "spacey feeling"" 23rd nausea dizzy general malaise 24th nausea dizzy general malaise 25th nausea dizzy general malaise Contacted Health Service 26th still nauseous dizzy general malaise and then chills Health Service Ordered Covid Test 26th negative Covid. 26th video appointment with PCP states no need for labs feels it's Vaccine related 27th minimal nausea no chills episodes of feeling ?spacey? and tired 28th Minimal nausea 29th Morning nausea and fatigue 30th Morning nausea and fatigue 31st increased nausea and fatigue all day easing as day progresses "spacey" with fatigue

Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscle aches, headache, and nausea about 2am, fever 99.8 at 1pm on 1/6/21. All these symptoms still persist now 5:40pm 1/6/20

Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.

12 hours post injection 7:30p, low grade fever 99F, queasy, brain fog and exhaustion. Fever went away over night, the rest of the symptoms stayed through the day.

Facial flushing, different sensation to head and ears, anxiety, unable to think. Pt. evaluated by MD, Benadryl 50mg IM administered with 1 hour in clinic observation. Pt. with improved breathing and relaxation, vitals stable.

Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache/ So much pain in my head; Couldn't talk; Complete brain fog; nausea; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (Patient) reported that received bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included Atrial fibrillation, Chronic Lyme, Lupus and Autoimmune. Concomitant medications included Metoprolol at 12.5 mg for Atrial fibrillation and acetylsalicylic acid (BABY ASPIRIN). No diabetes, no hypertension. None of the usual common diseases. Registered Nurse stated, "I received vaccine this past Wednesday. I was just talking to a couple of my colleagues and honestly I received the vac. at work. I did not really read through the paperwork and was 'weird' sharing reactions to the vaccine which for me was pretty bad reaction and thought like I need to go through your paperwork and report it. So I thought I should call and just give some information. The usual fatigue which I go to after being normal, my arm was not sore. However, as the week progressed into Friday I had a constant headache but it was manageable and then by Friday night my glands swelled, my nerves behind my ears, my neck and I was extremely fatigued, bad headache and went to bed and I had not gone out and finally I got out today I spoke with my Physician yesterday. What happened it looked like an encephalopathy but my head swelled, my face was all swollen, complete brain fog, fatigue and I couldn't talk. I was in so much pain in my head resulting in (incomplete sentence)." Lab work included the only thing is the PCR swabbing. No blood test. Registered Nurse further stated, "I don't know if that is important. But I will tell you and if it is you can send me the questions. I do have a history of Autoimmune. So my Physician thought that this was just like an enhancement of like my bodies reaction I have Chronic Lyme and I have lupus like my ANA has always been stressful. But we think that it is a family thing. No treatment for the Lyme. I did a lot of antibiotic and a lot of naturopathic stuff but that is in the past. But anyhow for anything else what I did was when I got the injection they said try and just take Tylenol not Ibuprofen but there was no way I was going to make it through with just that . So I took Ibuprofen. I called my Physician yesterday morning because I was not sure about what was is happening and I thought it might be secondary sinus infection or something else going on and it reassured me that it is definitely due to the vaccine. He said it is just your body's reaction, take the Ibuprofen, hydrate. Had me take what I had in my house Tigan for nausea. So I was extremely nauseous from the severity of the headache." Registered Nurse stated, "I just wanted to let you know what happened and the intensity of what it was because normally I would expect a headache. But this was a 'go dated'. Registered Nurse stated, "I guess the only question that I have is so do my work has this question and I was going to call my doctor tomorrow may be might know it better. I know that I have to take the second dose. But I understand the second round can be worse than the first. Is there anything that they are recommending that I can do may be prior to ease the reaction?" The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported clinical manifestations including swelling face and head swelled, which was suspected as encephalopathy by the reporting nurse, was probably related to the bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), due to temporal relationship. The subject's underlying Chronic Lyme, Lupus and Autoimmune were likely the risk factors to the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.

Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and moves. Diarrhea started 1-5-2021. No fever 97.7. Off work for 4 days. Using heating pad and inhalers. Has appointment with provider 1-5-2021 and 1-7-2021. Test for COVID on 1-7-2021 and negative Symptoms resolved 1-9-2021 and returned to work on 1-11-2021

four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and increased fever continued thru the night and not able to sleep, very restless. The next morning after I had more weakness and major flair up with my MS, where I fell several times and was not able to get myself off the floor. Each time I fell it too approximately 20 minutes for me to get either in bed or a chair. Still had fever of a 100-101 through out the day, took ibuprofen to help, which it did for a short time but then fever was back. About 7pm I took some Benadryl and was finally able to fall asleep. The next morning, no fever but very weak. Went to health club to help with my legs. This day was ok, weak but improved. No falls

Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: K5730, via an unspecified route of administration from 29Dec2020 16:15 at a SINGLE DOSE for covid-19 immunization. Medical history included migraine with aura. Concomitant medication included gabapentin, pravastatin, estradiol, diphenhydramine hydrochloride (ALLERGY), and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM). The patient previously took amoxicillin and had allergies. On 30Dec2020 15:00, the patient experienced pain at injection site, tiredness, chills, joint pain, fever and felt paralyzed at one point. The outcome of events was recovering. No follow-up attempts possible. No further information expected.

developed nausea and light headedness approximately 6 hours post vaccine. patient unable to report to work the following day, symptoms then resolved.

Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down. She went to see her doctor last week and was treated with benadryl.

reported "weird" sensation in her body and "like a pulsing in my chest". 1337 - Patient reports weakness,

Received shot at 10:53pm; I did take all of my medications and supplements listed except for the Thyroid medicine before going to before at midnight; very restless night of sleep. The pain in my arm woke me up. I never felt like I fell asleep. I woke up at 530am and took my Thyroid medicine and went back to bed until 6:30am. Felt fine until about 830am. I noticed I was starting to feel lightheaded and had this pressure on my head. I went back to bed and tried to fall asleep but really never did. I noticed that I would lose track of my train of thought often. Got up at 11am and took a shower and still just didn't feel like I had any motivation to do anything, so rested again. I then noticed my face, ear lopes and cheeks felt a little numb. I would pinch them and I noticed they were numb. Also, there was still pressure on the back of my head and on the bridge of my nose. Still light headed. I layed in bed until about 3pm when I did notice the numbness going away and the pressure on the back of my head and on the bridge of my nose getting a little better. Also, no appetite.

Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and foggy. Unable to fully concentrate on tasks. Flushed in face and unsteady lasting approximately 1 hour. Developed headache lasting remainder of shift. Developed body aches/chills in evening

Within approximately 2 hours of receiving vaccine, patient experienced slurred speech, dilated pupils, and was slow to respond to questions. Patient felt "foggy," similar to waking up from anesthesia.

Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Headache; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (batch/lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient worked at a hospital doctor's office. On 22Dec2020, the next day of vaccination, patient immediately for two days had "immense" (not clarified) headache and then had two days of vomiting and diarrhea. And she had been sick "ever felt" (not clarified) on an unspecified date. She had extreme exhaustion. She had been tested for everything from "manual" to mild "disease" (not clarified). She had extreme exhaustion, dizziness, shakiness, sore throat and Monday would be three weeks that she had been feeling like this. She had never been sick like that she felt like this way. She was supposed to get the second vaccine the day after the time of the report yeah so any way. They wouldn't give her because she was not feeling well but she wished just going to hold off and might be try it all over again in couple of weeks when she felt better but she really felt not well since had gotten this vaccine. She had never felt like this before in her life had ever felt this way all ever. She had taken an over the counter medication cold and flu medication (further clarified CareOne (batch/lot number: OCE2948, expiry date: Nov2021)), and ibuprofen (ADVIL, batch/lot number: R85569, expiry date: Mar2023) and she had been doing lot of sleeping. She had been sleeping nonstop. The patient underwent lab tests and procedures which included EKG and all kind of blood work with unknown results. Outcome of the events was unknown. Causality was reported as yes by the consumer.

WHEN I GOT TO WORK I DIDN'T FEEL AT MYSELF. I WAS DIZZY AND VERY SHAKEY AND DIDN'T FEEL RIGHT THE MAIN PROBLEM IS IF I CLOSE MY EYES AND GET REALLY DIZZY AND GET SICK AT MY STOMACH

Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS GSH ED Was given Benadryl, Prednisone and Pepcid orally Was discharged after 4 hours

Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up in nose felt weird and dry like menthol. Put ice on face. Took Tramadol. Having fatigue. Next day felt better, then started having brain fog difficulty remembering, vision is blurry, no energy and feel exhausted.

Extreme fatigue day of and following week of vaccine. On 1/20/21 had episode of brain fog or complete lapse in memory of event I talked to a person just the day before. (Never happened before) Today, 1/22/21 I was sitting at my desk talking to another person and fainted for no reason. (Never happened before). I came to and after short while felt better.. Left work to rest at home. Have not seen a doctor yet but worried about 2nd vaccine dose. The syncope episode concerns me.

Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentrating; nausea; severe headaches; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ElL0142), via an unspecified route of administration in left deltoid on 03Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included wheat allergy, celiac disease, and hypotension from an unknown date and unknown if ongoing. Concomitant medication included buspirone, cefixime (FLEXERIL), paracetamol (TYLENOL) and esomeprazole. On 05Jan2021 09:00 PM, the patient experienced fever 100.7, dizziness, fatigue, labile hypertension, confusion/forgetfulness, difficulty concentrating, nausea and severe headaches. No treatment was given to the patient for the events. The outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, PCR and Nasal swab both negative on 06Jan2021.

Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizziness, and horrible fatigue. Feeling out of it.

allergy like symptoms/allergy; nose running; congested and blockage in her nose; shortness of breath; couldn't sleep during the night; burning sensation in her chest; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the upper left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient reported that she took it yesterday and an hour into it she started having a burning sensation in her chest. What happen next, around 8pm, she started having allergy like symptoms that lasted throughout the night. She was experiencing nose running, congested and blockage in her nose, and shortness of breath. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. For treatment, she took Mucinex tablets for allergy. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. This was the first dose, her second dose is due on 02Feb2020 and she wants to know if she can skip it. Before she got it she contacted her primary care due to having allergies before the vaccine and asked if she should take; she was told to hold on but then she went ahead and took it. Within the first 30 minutes she was ok but in an hour is when she had the burning sensation in her chest. The burning sensation lasted about an hour. The dose was administered around 4pm on 12Jan2021.The caller reports that the Mucinex and she has breathing treatment, nebulizer treatments for her lungs, that she did and these things helped. Early this morning she felt she can now close her mouth and breathe normally. It was administered in the upper left arm. She did not require a visit to the doctor or ER. The patient has had no reactions to vaccines in the past nor were any administered on the day of or within the prior 4 weeks. Therapeutic measures were taken as a result of allergy like symptoms, congested and blockage in her nose and shortness of breath which included Mucinex. The patient recovered from burning sensation in her chest on 12Jan2021, from allergy like symptoms/allergy and shortness of breath on 13Jan2021 while the outcome of the other events was unknown. Information on the lot/batch number has been requested.

First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.

Severe Left Leg, Hip and Lower left leg pain (Sciatic Nerve) it appears the vaccine may have irritated sciatic nerve pain. Left left leg numbness. Decreased mobility, difficulty sitting, walking, and even lying in bed. Started very quickly without andy known injury. Pain continued to worsen. Pain even worse after second injection. Now two weeks after second shot, the pain is going away. It is like the nerve irritation is subsiding. The way the irritation is subsiding makes it seem that the vaccination may have caused irritation to the nerve. After receiving 1st and continuing through the second vaccine, started having severe sciatica pain going down left hip and leg. Left leg pain and numbness. Thought I had done something to damage the nerve. Hurt to sit, hurt to stand and even hurt when in bed. The pain was so severe it caused issues with any mobility. Took Advil, Aspiring, Tylenol and nothing helped. Received second vaccine 1/12/2021 the pain continued and even got worse. It was to the point I couldn't even walk. I couldn't figure out how I had damaged the nerve. I am now thinking it was from the vaccine. I believe the vaccine irritated the nerve. The nerve pain is starting to go away. Normally if you have a sciatic nerve issue, it just doesn't go away on its own. I know there have been reports of severe back and neck pain. I believe it can irritate the nerves which cause severe pain. I wanted this reported in cases others complain of similar issues. The good thing it is improving.

pt stated about 2 hours after receiving her covid vax that her heart was racing, beating harder than normal but subsided after about 2 hours. She was about to go to the ER but waited a little longer since she thought she was just having anxiety issues and did not have to go. She will contact her PCP today to let them know and discuss getting the second dose.

Received vaccine #1 Phizer on Jan 5th 2pm. Started to feel tired by 7pm. 5am woke up achey with general malaise. Took Tylenol 500mg and came to work. I started the attestation form and called employee health to let them know about my aches. They recommended me getting tested for Covid 19 in which I did before I left at 8:30am. My health continued to decline as I became ferverish, with a headache, nauseas, foggy, and exhausted. When I got home, I couldn't get off the couch. I felt horrible for 36hrs. My headache lasted for 5 days. Covid 19 test and flu test negative.

Received Phizer vaccine dose #2 Tuesday 1/26/21 at 0915. Feverish and tired at 6pm(8hrs 45 min later) Wed 1/27/21 5am fever, aches, chills, foggy, slight headache, exhausted. Wed 1/27/21 7pm exhausted, foggy Thurs 1/28/21 5am exhausted, foggy, no reserve Fri 1/29/21 5am tired, foggy Sat 1/30/21 Much better.

Was okay Friday morning then stomach started getting upset Friday night and I tried to eat food to calm down. A slight headache was starting. The next morning I had a massive headache all day Saturday, by 8 PM it was a full-fledged nauseating migraine. The severe migraine lasted from 8 PM the previous night to 10 PM on Sunday night. By Monday I was doing better but a bit confused and having difficulty thinking. Now it is Wednesday and I am a bit exhausted and still having trouble thinking but doing so so much better! I am so happy to be feeling better!

slurred speech/ responded slowly to questions within 2 hours of receiving the vaccine; dilated pupils; "foggy."; This is a spontaneous report from a contactable other hcp. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248), intramuscular on 19Jan2021 09:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and oedema. Concomitant medication included phentermine hydrochloride (ADIPEX-P), olmesartan medoxomil (BENICAR), furosemide (LASIX), amlodipine besilate (NORVASC), doxycycline (VIBRAMYCIN). The patient previously took Ciprofloxacin, Clopidogrel, Meperidine, Flagyl, Macrobid, Penbutolol and experienced drug hypersensitivity. The patient had the first dose of vaccine on 20Dec2020 (Lot number=EK5730). The patient exhibited slurred speech, dilated pupils and responded slowly to questions within 2 hours of receiving the vaccine. The patient felt like she just woke up from anesthesia and was "foggy" and 19Jan2021. The outcome of the events was unknown.

I had covid Sept 26th 2020.The day after the second shot I had covid symptoms. Seven days later I still have chills,fever,muscle aches and fatigue. I am going for a covid test today.I have missed days of work due to this vaccine.

I got up and had a really bad headache and fatigue. I did not go to work due to the headache. I took a Tramadol, got an ice pack, placed it on my head and put some lavender on my pillow, called into work and went back to bed. I still have the headache and fatigue, but I am able to work so far.

At 2:30 pm after being in observation for 30 minutes, patient became concerned about a rash to her left arm. There was a small area that had a lace modeling appearance. Patient denied any pain or itchiness to this area and there were no hives. Patient very anxious and concerned and asked if she could take her own liquid Benadryl which she had on hand. She was offered Benadryl from the clinic but refused and really wanted to take her own. Approval from supervisor obtained and Benadryl was verified. VS BP 110/60, HR 76 and pulse ox 98% at 2:35 pm. Patient denied any other signs and symptoms of allergic reaction except anxiety. VS repeated at 2:55pm and were; BP 110/60, HR 68, Pulse ox 100%. No change in condition and patient felt good enough to leave. Patients sister accompanied her to the clinic today and will stay with her tonight.

1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that day; blood work. Declined IV fluid. Monitored vitals. Body aches continued that weekend, went back to work the 14-15th but 'pushed it' to go back. 1/17 ER - blood panel; negative. Admitted to Inpatient to monitor heart and MRI of brain. still experiencing dizziness, 'disorientated'

12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache occurred. The symptoms lasted all day and were mostly gone except for a small headache and fuzzy brain after 30 hours. All clear after about 36 hours.

High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking on the outside. Headache & extreme stomach pain. Which all of this has made it to where I'm unable to work.

Had trigger finger in right hand lasting 3 days -resolved. Began experiencing tingling and electrical impulses down both legs (no pain). This becomes worse with walking. Comes and goes throughout the entire day and wakes me up at night at intervals. Began 4 days after vaccine and has continued since.

The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and globus sensation pale and tremulous. Nurse noted that she had a 4mm hive above her lip. The treatment of the reaction was: o Epinephrine: x1 Transferred to ED

Pt reported tachycardia post receiving vaccination. Pt reported PMHX of anxiety. Symptoms response within 5 minutes. No Treatment or Transport.

2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.

About 12:30 AM on 2/14/21, I woke with extreme chills, muscle weakness, possible fever and sweats, joint pains. About 2:30 AM, I took two 325 MG aspirin. About 9:30 AM, I woke again with the same extreme symptoms listed above. I took an additional two 325 MG aspirin. About 4 PM, my symptoms were not as severe, but I was still unable to engage in daily activities, and I took an additional two 325 MG aspirin. Symptoms continued, but lessened, and about 9 PM, I told an additional two 325 MG aspirin and a zolpedim CR to help me sleep throughout the night. I woke about 6:45 AM on 2/15/21, with mild muscle weakness, joint pain, and feeling slow and tired. As of this report at 11:15 AM on 2/15/21, I am functioning at about 80% capacity, some chills and muscle/joint pain.

shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakness, fatigue all over, numbness in feet and hands, two -three weeks of morning anxiety, difficult to operate a car, two tp three weeks stiffness in joints, and headache.

1/6 1:30 vaccination Later that evening, I had extreme HA. I had 2-3 aura migraines, a day or 2 later. Insomnia. *still experiencing insomnia and anxiety

Right after the vaccine I felt a little funny. Within 10 minutes of receiving the vaccine I started coughing, lost my voice, Itchy eyelids, my chest was pounding, and overall just did not feel right. EMS Took my blood pressure and it was 255, then they waited a smidge and decided to give me an injection of Benadryl, within 10 minutes of the Benadryl my blood pressure went down to 225, and I overall felt a little bit better. My eyelids were still swollen and itchy and I didn?t have a voice, they took my blood pressure again and it went down to 218. They stayed with me. I was starting to feel a little bit better. My blood pressure went down to 180 and there?s no wheezing in my chest. They let me leave shortly after that. I still do not have a voice. My eyelids are still swollen slightly and very itchy and my lips tingle.

Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , headache, cough, fatigue, upset stomach, diarrhea. Subsided in about 36 hours.

12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minutes. Left after. Later that evening, I felt like I was on 'speed'. Chills, HA, couldn't sleep. HR was increased. I wasn't able to eat; no appetite. Symptoms lasted for several days. Don't think I ran a fever. I was very dizzy, double vision, extreme fatigue. Did what i could with work online. *HX of aura migraines and happened during this episode. Within that week, saw NP.

Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for about 10-12 hours, then lessening to feeling tired, bouts of vertigo and occasional headache. Five days later on 1/25 I experienced blurry vision, nausea, confusion, dizziness, and impaired speech (to a co-worker). This lasted about an hour.

Pfizer-BioNTech COVID-19 Vaccine EUA At 2:30 am woke up with nausea and stomach ache. Continued through the night. I could not sleep. In the morning (9:00) I tried to sleep but had very bad chills for over an hour. Went down to couch and covered up with many blankets. Chills continued for 4-5 hours. Also experienced tiredness, and general 'feeling unwell' throughout the day, as well as extreme heartburn. I stayed home from work and sat on the couch all day, feeling unwell. By about 8pm all of the symptoms disappeared.

This is a spontaneous report from a contactable nurse. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), other route on the right arm at the age of 60 years, on 02Feb2021 12:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included depression Depression, Hypothyroidism, High Cholesterol, Osteopenia, Occasional vertigo. Concomitant medication included simvastatin (SIMVASTATIN), duloxetine (DULOXETINE), raloxifene (RALOXIFENE), chlorthalidone (CHLORTHALIDONE), levothyroxine (LEVOTHYROXINE) , calcium (CALCIUM), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), folic acid (FOLIC ACID), fish oil (FISH OIL), vitamin b12 nos (VITAMIN B12 NOS) , calcium carbonate, colecalciferol (VITAMIN D 2000) and Tumeric. The patient had the first dose of vaccine on 12Jan2021. After the 2nd shot, the patient's arm didn't get heavy, just felt a weakness going from shoulders down to hands on Feb2021. She couldn't move or feel them for 15 min. Slowly she could move her fingers then hands then lift arms. The next day her brain felt kind of fuzzy and still a little "off kilter" on 2nd day (Feb2021). She did not have any anxiety about either shot, even with what happened with the first one. The outcome of the events was recovering.

Left shoulder has periodic pain and stinging as if someone with a heavy hand is giving me an injection now. The pain wakes me up at night. Sometimes in the day I feel the pain level at about a 6.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient explained she was very anxious, light headed, flustered, headache - more than 15 mins after the dose. She waited the 15 mins and when heading home, felt sick and returned to the pharmacy where the staff sat with her for an additional 30 mins

slight fever for 2 days, then flu-like symptoms (body aches, fever, chills, lack of appetite, loss of taste and smell, fatigue) since Wednesday 2/24/21. Missed work due to symptoms on Thursday 2/25/21. Returned to work amidst continuing flu-like symptoms on Friday 2/26/21. As of Sunday, 2/28/21, symptoms continue; maybe slightly diminished.

At first I didn't feel anything or any different. I started to get a weird sensation behind my eyes like before with the first vaccine. The muscles of my eyes and eye lids feel weak and difficult to focus. I started having extreme nausea and could not go to work. No appetite either. I now have Oscillopsia and feel sick.

Pt was observed to drop her phone on the floor. When it was picked up & RN attempted to hand it to her, she appeared to be sleeping. She did wake after physical stimulus but was lethargic, confused & stated she "felt dizzy"

COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD

Starting about one hour after the injection, my left shoulder began to hurt a little bit. As the day progressed the pain increased substantially into my shoulder. It then started to hurt on the left side of my neck. I took Tylenol before bed, 500 mg is all I can take. This pain kept me awake all night and this morning I am not able to lift my arm up or down or sideways without pain, quite a bit of pain. Today is Sunday and I do not plan to seek medical care unless it continues to worsen. I will probably talk with my medical provider tomorrow if this continues.

I received the shot at 4:30 pm. About an hour after receiving the shot, I felt a little dizzy, and my heart started beating faster. My body felt weird. I had a small headache and was very tired and laid down. I fell asleep pretty quickly. I woke up around 2:30 am the following morning, with a greater headache. I took tylenol for the headache. I took another dose of tylenol 4 hours later. I had loose stools, fatigue and my lungs felt heavy (cough) for approx 12 hours. Most symptoms resolved by the following day. A little fatigue and heaviness remains.

Beginning 20 hours after vaccine, became extremely chilled and fatigued followed quickly by pain in all bones of body - face bones, leg and arm bones, ribs, etc. Thinking became foggy - everything became difficult to do. I went to bed at 7:30 pm on 2/25/2021 - slept fitfully until 6:30 am on 2/26/2021. All symptoms had lessened by 30%-50% during the day on 2/26/2021. By 2/27/2021, I felt pretty much like me again.

Syncope, difficulty focusing- Evaluated by EMS-Transported to Emergency room/department or urgent care.

Saturday, March 6 felt fine all day with normal activity. Woke up at 7:05 am Sunday, March 7 with dizziness, nausea and sweats that would last about a minute. Remained sitting still with my eyes closed about 3 hours and then eyes could be open but could not move without the dizziness and subsequent nausea. I did not vomit. My temperature was-low in the morning but climbed just to 99.3 Sunday. By Sunday afternoon, I no longer had the short sweats but remained dizzy and nauseous mostly upon any movement. I went to sleep at 11:00 pm Sunday night with the slight 99 fever. Woke Monday , March 8 much improved from the dizziness and temperature 98.6., but felt extreme tiredness. I did not go tot work Tuesday and rested on the couch most of the day-temperature 98.6.

On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3, chills, body aches and weakness On day 4 after second dose had severe back pain, painful to walk, despite taking Motrin. Went to doctor and had MRI done. Then by early February started having insomnia, hard time falling asleep and staying asleep . I feel the second dose of vaccine might have caused my immune system to become over active. The back is now ok after rest and physical therapy but the insomnia still persist.

1/11 vaccination 1/12 I just had body aches, chills. 2:13 PM i was on my couch, I could hear myself having trouble breathing while dreaming. I sat up, elevated, and went back to sleep. SOB that afternoon. I slept and woke up the next day and felt fine, went to work. 1/14 I worked all day. 3:10 I couldn't breath. Was with my neurologist. Pulsox was 79. I went to the ER. Hooked me up to IV, chest xray. Dr. said anxiety was up. After 4.5 hours I was able to go home. symptoms subsided.

Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started around 1 pm March 8 and subsided by 8 am March 9

2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves. Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore. Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone. No headache

After receiving her vaccine, client stated she felt lightheaded and anxious. Vital signs obtained by EMS BP 177/106, HR 83, O2 sat 99%. Client stated she feels better. Client discharged home.

Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt taken to vaccine clinic observation area to be closely monitored. Pt placed on gurney and given water to drink. VS stable. Pt report headache 5/10, feeling sensitive to light, and nauseated. While in observation area pt reports feeling what she describes as "feeling weird wavey sensation over entire body, warm head, and cool body." Pt offered but declined to go to ED. explained risks and benefits to pt. Pt states that she drove herself to vaccine clinic. Pt advised that it it would be unsafe to drive herself home and advised to to contact husband for ride home. Pt called her husband to pick her up. After several min pt states stated that she was "feeling a little better" and "headache was also a little better" 3/5 on pain scale but still feeling dizzy and chest feeling a little tight. " Pt states having a history of Asthma. Pt again offered to be treated in ED and accepted. Pt transported to ED by gurney accompanied by three RN's.

experienced chills and body pain on the 3rd day after receiving the 2nd dose vaccine . chills and body pain lasted for 2 days . on the fifth day felt like black curtain in front of my eyes and felt dizzy. checked my blood pressure was 170/90. Blood pressure went up to 200/100 . went to the hospital emergency and was admitted for observation overnight. CT, MRI , blood work done. BP controlled with medication Nefidefine 60mg. discharge home next day. was still having very light headedness and BP will shoot up to 190/90. physician had to change the medications couple of time. felt very exhausted . could not go to work almost 3 weeks because of the symptoms like lightheadedness. lasted at least 4 weeks to get back to work normal. never experienced this before. I was taking Olmasartan 5mg for blood pressure and my Bp always stated 130/80s

Pt in COVID-19 Observation Area complained of weakness to body. Per pt felt dizzy and anxiety earlier but better now. . B/P @ 141/92 02 Sat. @ 96-99%. Doctor evaluated pt rechecked B/P @ 100/50 02 @ 96-99%. After evaluation pt states less wekness to body. Pt keep in Obsrvation area.Pt felt better and wants to go home Doctor notifed. Instructions given to pt to go to Urgent care or E.R. @ Medical Center if sympyoms worsen and return tomorrow if s/s continue. Can be discharged. Pt accompanied to vehicle to daughter. Instruction given to daughter verbalized all discussed.

Just a few hours after receiving my first Vaccine, I started running a fever of 99.9, Got real sick at my stomach, started have Diarrhea, Severe Headache, My arm hurt really bad could not use it for a Day and 1/2. Just felt like I had been run over by a Bulldozer.

Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pain on and off; Arrhythmia; This is a spontaneous report from a contactable physician. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 11Feb2021 09:00 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history included (G60.9) PN - Peripheral neuropathy (SCT42658009), (M79.2) A Neuralgia (SCT16269008), (R55) Syncope (SCT271594007), (I10) HTN - Hypertension (SCT38341003), (R00.0) Tachycardia (SCT3424008), (E16.2) Hypoglycemia (SCT302866003), (R55) Vasovagal symptom (SCT248229009), (M25.50) Joint pain (SCT57676002), (F41.9) Anxiety (SCT48694002), (K21.9) Acid reflux (SCT235595009), and (M06.4) Polyarthritis (SCT416956002); all were current or ongoing. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 12Jan2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, administration time: 09:00 AM, route: intramuscular, vaccine location: left arm). On 11Feb2021 11:00, the patient experienced dizzy, nausea, vomit, pain on all body, frequent fall, severe fatigue, strange feeling, abdominal pain on and off, and arrhythmia. The AEs resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. There were no treatments given for the events. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID post vaccination. The patient has no known allergies. No other vaccines received within four weeks prior to COVID vaccine. The events were reported as serious and disabling. The patient has not recovered from all the events. Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Had vaccine on Tuesday, 3/9 and on Thrusday night and Friday evening , my right elbow area was very sore. The pain is very localized and responded to a couple of days of ibuprophen. Started again this week and the arm is swollen/inflammed. Uncomfortable for daily activities like typing or eating. Does respond to ibuprophen. Trying to rest it and have it in sling to rest it.

Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, violent headache, chills fevers ,dry heaves, red and hot arm developed after couple days lasted about six days spread to 4x6 inches got itchy then sore to touch. Became vague and almost disoriented, had to sleep due to overwhelming fatigue w vile headache

Severe debilitating fatigue that began the day after the vaccine (as expected), but has persisted; fatigue is so severe that I have had to stop working. I am a physician doing telemedicine

Pfizer-BioNTech COVID-19 Vaccine EUA Date of Tuesday, Mar 16, 2021. Intense neuropathy pain in both feet and both lower legs mainly at night. Difficulty sleeping. This continued each night but during day of Friday, Mar 19, 2021 the neuropathy continued and the numbness and tingling migrated up into my legs and into my arms and hands but not as intense as in my feet and lower legs Tingling, shakiness felt in muscles is continuous now, not just at night. I was scheduled to have 2nd dose today but decided not to go through with getting it. Consulted with my APRN on phone and they advised to get 2nd dose and we would follow up if needed on neuropathy. I decided I did not want the 2nd dose.

03/19/2021 - 4 PM I STARTED TO NOT FEEL WELL. LEFT WORK - WENT HOME , STARTED TO SHAKE REALLY HARD WITH COLD CHILLS. LAID DOWN WITH TWO BLANKETS AND WAITED FOR THE SHAKING TO STOP...THEN FELL ASLEEP. I AM GUESSING SHAKING WENT ON FOR A GOOD 1/2 HR TO HOUR. i WAS VERY WEAK TO GET UP TO GO THE BATHROOM. MY HUSBAND HELPED ME.

8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness. Initially I noticed my knees hurting with radiating pain up into my thighs. My head hurt, particularly at the back of my skull, near my neck. My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder. I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms. She told me I could take either and alternate if I felt I needed to maximize relief. I noticed the joins in my toes and fingers were hurting. It was frightening to experience tightness in my chest and back muscles. I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted. I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get. I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse). I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding. She encouraged water and more painkiller. As the day wore on, I felt less achy and more shaky/jittery. My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy." As I write this 36 hours after my injection, my symptoms are subsiding. Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body. It isn't a fever - just an odd sensation that something is still going on.

Patient was walking to the bathroom when she became dizzy. Patient provided with chair on her walk to the bathroom and made aware that we needed her to be stable before getting up again. Patient took a 5 minute rest and felt better. Patient guided to the bathroom but once she came out of the bathroom she became dizzy again. Patient was provided with a chair again but started to become frantic so we provided her with a cot and laid her down but patient started to become very short of breathe. Medics called and provided with hand off.

March 21 I had fever 101 , fatigue, nausea, body aches, headache that kept me from my daily functions. Reporting app did not ask about that date and I want to report that was a bad day. I did not seek medical treatment. Treated with ibuprofen and rest

Within 1 hour after receiving vaccine, approx 45 min., Both ears suddenly felt as if I was on a plane and was blocked as you would feel by altitude change. I kept trying unblock by swallowing etc. That last 15ish minutes followed by a constant sound in both ears as if someone was rubbing sand paper back and forth in front of each year. That lasted 40-50 minutes. Approximately 32 hours after feel like I have to keep swallowing to unblock my ears. That altitude flucuation again feeling but not as bad as the first encounter. This was related to the vaccine. No doubt in my mine. Never had anything like this before unless on an airplane. Sand paper sound, never. I let my physician know tonight via email. In addition I felt dizzy within 5 minutes of receiving the injection. Subsided within 15 -20 minutes. Felt aloof the remainder of the day. Also arm hurt so bad the next day I had to cancel golf. Low grade fever plus headache

I could actually feel the vaccine entering my blood stream above and below injection area. I had sharp pain on right upper side of my chest that came and went for several hours along with dizziness. Arm hurt so bad later that night from my elbow to my neck it woke me up and I took aspirin until pain died down some.

Felt abnormal and went to bed. Woke up at 9:35am with 101.7 temperature and called into work to advise I will not be coming in. I went back to bed no food no medicine, Most information I read and was aware is that it would be better with sleep. Only to wake up at 8:30pm with a 102.7 had 500 mg acetaminophen went back to bed. Woke up Thursday morning at 9:45am fever free. Friday afternoon I noticed swelling on my left neck area. Just inside my left clavicle. I made a Dr appointment for Monday and Dr. found several Lymph nodes swollen as well as under my left arm pit area. Due to some chest pain she sent me for a chest x-ray.

Extreme exhaustion, chills, muscle aches, brain fogginess, headache - all the symptoms I experienced when I had COVID-19 in early November 2020. All symptoms improved within 18 hours except headache, which lasted for 36 hours. Headache was also a lingering effect after all other COVID-19 symptoms subsided when I had the virus, as well.

Began to feel bad one week after receiving injection and made appt with provider, xray showed infiltrate, pnuemonia, in right lower lobe, antibiotics prescribed and taken increased shortness of breath at time of visit.

The injection was in the shoulder. Pain began less than one day later. I waited for the pain to resolve. It has not. My shoulder is still sore. The pain is getting progressively worse and it now hurts to comb my hair, it hurts to raise my arm to put dishes in the cabinet, and it is hard to carry lift and carry objects of 8 ounces more. This pain also make it difficult to sleep through the night.

Initially, mild nausea, immediately (with 15 minutes of administration) . Resolved promptly within 30 minutes of injection. Then, three hours after administration (at approx. 12.30 p.m.), the following symptoms in order of severity: 1. Severe tiredness/fatigue. Lasted 4 hours. Resolved when I took a half hour nap. 2. Sore throat. Still present at 10.30 pm. 3. Swollen lymph nodes (lymphadenopathy). Significant improvement after 4 hours from onset (3 hours after administration). However, still present at 10.30 p.m. 4. Feeling unwell/malaise. Resolved after I took a nap. 5. Dry eyes. I had to remove my contact lenses and put on eyeglasses when I got home at approx. 2pm. 6. Dry mouth. Unresolved, even with drinking a lot of water and tea. Symptoms were fairly severe. I had to leave work and go home to rest. I was unable to drive myself home.

Day 1..... couldn't sleep that night Day 2.....fever, chills, bad headache, fell asleep at 4pm and slept all night with 800 mg Tylenol. Day 3.....fever, Chills, bad headache, cough, diarreha Day 4..... headache, cough diarreha

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: vomiting-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe

pt. reported hx of anxiety and forgot to take medication. BP 152/84. HR-WNL. pt. now wants her BP checked. No interventions other than reassurance. pt. verbalized understanding to call 911 for any assistance after leaving clinic.

Feels dizzy but thinks it may be anxiety. No other signs or symptoms. Informed to seek medical advice if any further problems.

I'm fairly certain that the vaccine caused a severe fibromyalgia flare-up, about 3 days after getting the vaccine. This flare-up has been much more severe than the ones I usually get. The pain, fatigue, and brain fog has been extreme. No fever or flu-like symptoms.

my body is killing me; body pains; fever/Had a 101 fever at night; experienced ulcer on the side of her tongue; eye stye/I started with some kind of infection like stye something; felt terrible/ I am just feeling bad/Started freaking out; Swollen eyes/more puffy; irritable; stressed/Shot stressed my body; headache; Drug sensitivity/Reaction to medicine; I didn't have a taste; my 'eye' also started getting kind of sore; And then 3 days later, it started with an ulcer in eye; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Formulation: Solution for injection, Lot number: EN6204; Expiration Date: 30Jun2021), via an unspecified route of administration, in the left arm on 12Mar2021 around 1:15- 01:20 PM (at the age of 60-years-old) as 0.3 mL, single for covid-19 immunisation. Medical history included arthritis, anxiety and I had the virus in November. Concomitant medications included meloxicam (MOBIC) taken for arthritis as needed; alprazolam (XANAX) at 1 mg daily for anxiety. On an unspecified date in Mar2021, the patient had body pains, had a 101 fever at night, headache, ulcer on tongue, swollen eyes, stye in eye, felt terrible/started freaking out, irritable, drug sensitivity/reaction to medicine, shot stressed my body. Consumer stated, I had gotten the vaccine the other day, Friday. You don't know me but if you know me, I am going to have the side effects and it's going to happen, and it happened. From the next day my body is killing me. I had a 101 fever at night, felt terrible. Anyway, the next day, I felt better, whatever. And then yesterday, I felt pretty good except I started with all of a sudden, I got ulcer on my tongue. Now, I have got like, I don't know a stye happening on my eye and I know, it's all due to that vaccine because I have reactions to the medicines. I got to watch what I do. And I was scared to get this thing anyway, I already didn't want to get the shot and I did it. But anyway, right now, I am just feeling bad because of my tongue and I kind of looked up that and it did say that it can be caused from like a drug sensitivity. I do know it's all because of that." Consumer further stated, "Like 3 days later, I started with some kind of infection like stye something on my eye. Yesterday it started, and also, I have an ulcer on my tongue now. But I guess what I am afraid of, in less than 3 weeks, I have got to take this vaccine again. The patient had the virus in November, and I did test positive at some point for the antibodies and when I looked up something, as I was running a high fever. I started looking up stuff and it said if you already have a pre-existing immunity which I did due to the antibodies. I believe it's still there because it has been 4 months, but you might get. It says you will get side effects worse; you will get side effects. People that have never got exposed and have antibodies, don't get the side effects but I got them. So, I guess what I am afraid of because now I am like, I know it's a reaction to the medicine. And now I got ulcers on my tongue. And my eye, yesterday it started with the stye thing, and I never get them, it was swollen. I know this was a reaction from that vaccine, I know it was. I don't have fever and none of that no more, the body aches have left me. It was pretty bad, but it left me. But I am scared to get that next vaccine. Consumer stated, my 'eye' also started getting kind of sore and now it's swollen and I know this was a reaction to that because my body did not like that's all I can tell you. I am afraid if I get the next vaccine which was on 02Apr2021 (later confirmed), am I going to get, I am scared that something worse is going to happen to me. Because everybody knows if you had the vaccine, any of them, nobody and they say with the first vaccine usually you don't get anything, it's the second one. Well, I know, it was going to happen to me, and it did happen to me. So, I am scared what's going to happen with the second one. If my body still has antibodies from the virus, it did say or I read, maybe it's not true but what I read, it said 89 or 87% people that have already been having pre-existing immunity which would be me because I had the antibodies, you won't get the side effects more than people that never had the antibodies or had the virus. I didn't have a taste because I was having a high fever initially when I had the virus. It was weird. I cannot explain the feeling. I was laying down that night, that Saturday night, I thought let me check my temperature and it was like 99.5 and then maybe an hour later 100 and at 1:30 in the morning, it was 101 and then a couple of hours later, I checked it and it was like down to 100.5. I was calling a Pharmacist when I started freaking out on that. And they said no, nothing was going to happen. On Sunday morning, it was 99.5 and then when I checked it yesterday, I had nothing, no more fever. But then I started with ulcer and I looked it online and it said that it could be due to the stress and I was very stressed out because of getting a shot. I didn't want to do it and I did it but one of the things, it said a sensitivity to foods and drugs can cause ulcers in the mouth and I know it was that and then my eye, I don't know about the eye, it's swollen underneath. I know this was a reaction, I know it was. Eye was a little worse. I guarantee you, it's due to the shot. Shot stressed my body. That was just my reaction to that shot because it started all the side effects. And then 3 days later, it started with an ulcer in eye. And I guess that it's just too coincidental. It just stressed my body bottom line. The eye was a little bit worse today. The ulcer was going to go away, but it is at its peak right now. I am worried about the eye. It started sore yesterday and then today it is more puffy and I kind of put my contact lenses on it. It's not in the eye. It's on the tissue of bottom lid near the edge of the eye. The patient underwent lab tests and procedures which included blood test which showed okay, everything was okay. Therapeutic measures were taken as a result of ulcer on the tongue included had a mouth wash that she used and had done great to my teeth. The ulcers are going to go away, but the eye was. I am just kind of watching it if it gets like whatever tomorrow. I might go to emergency room. It's not in the eye. It's in the lower lid. It's very tender and close to eye." Consumer further stated, "I want to know an answer. This is really important to me because this time, I have to take a nerve because as soon as they put the needle in me, my nerves, I just had a panic attack. I was scared. I need to know do I need to afraid to get next vaccine because I won't do it if I knew something worse going to happen, I won't do it. I already have the reaction, but I don't want to risk our lives again. I got the side effects. Consumer stated, I'm a little sensitive to the medicines. I keep a check on what do I take. The outcome of the events body pains and fever recovered on Mar2021, ulcer on the side of her tongue, felt terrible/ I am just feeling bad/started freaking out was recovering, swollen eyes/more puffy; eye stye/I started with some kind of infection like stye something; my 'eye' also started getting kind of sore; And then 3 days later, it started with an ulcer in eye was not recovered and other events was unknown. Causality assessment for events had a 101 fever at night, ulcer on tongue, swollen eyes with BNT162B2 was related per reporter.

She got the vaccine, only had the real sore arm. She went to bed and trying to get ready to go to work, had a slight fever, headache, chills, aches, stomach didn't feel right. Felt like she had the virus again. She was in bed all day on Friday, and then that night she still had chills and 101.1 fever. Did not feel well on Saturday and was out of work for 2 days. She is feeling better, tired. The arm is still sore to touch, but not as bad. She just felt sick, and is feeling better today. Her stomach is still not right, but overall feeling better. She did take Tylenol which helped and a couple of other times for the symptoms.

Massive headache at front of head, dizziness, ringing in ear, nausea, restless, diarrhea, stomachache, shallow breathing, hearing sensitivity, exhaustion, sleep sweat, lack of appetite.

TINGLING IN THE CHEST ABOUT 1/2 HOUR AFTER SHOT, FEELING OF SWOLLEN LIPS STARTING ABOUT 2HRS AFTER SHOT LASTING ABOUT 4 HOURS..THEN TONGUE AND FACE FELT TINGLING ..TONGUE FELT SWOLLEN METAL TASTE IN MOUTH AND A VERY FUZZY FEELING FOR THE DAY OF AND DAY AFTER SHOT WENT TO WALK IN CLINIC AT 620 PM ON 4/3. RECOMMENDED BENEDRYL RATHER THAN STEROID METAL TASTE AND FEELING OF SWOLLEN TONGUE SUBSIDING....FACE TINGLE REMAINS ON 4/6/21

rapid heartbeat; she has been having insomnia ever since she went to the hospital; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration administered in the right arm in a hospital facility on 10Mar2021 at 12:30 PM (at the age of 60-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks and had no additional vaccination administered on same date of the Pfizer suspect. The patient had no medical history (including any illness at time of vaccination. The patient had no family history. Ongoing concomitant medications included amlodipine besylate from 2019, vitamin D3 taken for general health, calcium taken for bone density, and fish oil taken for heart health. On 12Mar2021, the patient experienced rapid heartbeat. The patient continues to have rapid heartbeat "on and off." The patient asked if it was considered a severe allergic reaction. The patient added that she went to the ER and was admitted to the hospital on 12Mar2021 and discharged on 14Mar2021 due to rapid heartbeat. While hospitalized they did an electrocardiogram (EKG); and Echocardiogram and a computerized tomogram (CT) of the heart and chest and all showed no heart disease and no pulmonary embolism. Adds whenever she gets up and does some slight activity, her heart goes for about 30 seconds. Sometimes it goes from 70 to 115 and then goes back. also added that she was going to see her primary care doctor on 29Mar2021 about it. She was scheduled to get the next dose but she was asking if she should get the next dose. She also added that she has been having insomnia on 12Mar2021 ever since she went to the hospital and it was still happening because she was so anxious about this. The events did require emergency room visit but did not required physician office visit. Therapeutic measures were taken as a result of rapid heartbeat which includes amlodipine and metoprolol. The patient had not yet recovered from rapid heartbeat and insomnia.

March 28: Bright red cheeks, extreme thirst, cold sores, severly chapped lips, clammy sweat (continued through entire series of symptoms) March 31 - April 2: Fever, Chills, Excrutiating muscle and joint pain, nausea, severe headache. Unable to function, think clearly, or eat/drink. No vomiting April 2 - April 5: Severe upper stomach pain and burning/soreness under right side rib cage. Uncontrollable watery diahhrea. Unable to eat the first two days of this. Able to drink some. April 5 to current: Still fighting the diahhrea but pain stopped. Have been on the BRAT diet since April 4th. Began taking a prescription from doctor to help with diahhrea on April 8. Still experiencing dizzyness, lack of clarity.

shortness of breath, chest pain, altered mental status, weakness, hallucinations, admit to hospital and discharged on 4/2

Numbness and tingling of tongue and lips. Patient reports she felt and still feels nervous and anxious about COVID vaccine. Vitals when arrived at meds observation at 11:09 am, HR96, resp 18, BP 183/89, 98% SaO2. BY 11:11 resolving numbness and tingling of mouth. Vitals at 11:12am, HR 95, Resp 18, BP 171/85, 98% SaO2. At 11:20 am, patient reports only slight numbness and tingling in tongue, lips resolved. Vitals at 11:20, HR 94, Resp 18, BP 165/80, SaO2 98%. Patient came back from bathroom( assisted to & from bathroom by med obs RN), vitkas when back at 11:33 Hr81, resp 18, BP 194/82, SaO2 100%. Rechecked vitals 11:39, Hr 88, Resp 18, BP 180/80, SaO2 97%. Vitals at 11:56 am, patient reports most of tongue tingling is gone, Vitas at 11:56, HR84, Resp 18, BP 174/87 , SaO2 98%. Vitals at 11:49, HR 93, Resp 18, BP 164/83, SaO2 97%. Patient anxious and wants to leave. Vitals at 12:05, HR 86, resp 16, BP 184/84, SaO2 97%. Spoke with provider about patient's situation. Okay for patient to leave since being worked up by PCP for HTN. Patient instructed to check BP once she got home (has been monitoring BPS at home due to HTN) and notify PCP about BPs while here. Patient's vitals at time of leaving via own personal vehicle, HR 90, Resp 16, BP 183/83, SaO2 98%. Patient reported only a little tingling in tongue when she left.

Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium

around 1106am patient complained of "harsh" throat and "just not feeling right" EMS on scene performed EKG 11:10am patient had emesis, 118/72, HR-76, 98% on room air, PA evaluated pt on site and ordered Hydroxyzine 25mg po x1. pt took this and has no complaints.

Almost immediately felt flushy and a bit hyper and then started to develop numbness (not pins and needles) of the front of my face. Somewhat milder than for the first dose, both of my upper arms started to feel discomfort within a few minutes. The numbness dissipated within an hour and a half, by which time I started to feel achy and have some of the common side effects. Next day was very achy and did not have much stamina. Was feeling much better in the morning of 04/11/2021. In the evening of 04/11/2021 started to feel some numbness in my nose again.

Mild to moderate hallucinations for about 10 hours, starting about 6 hours after vaccine. insomnia & restlessness - at its worst during first 24 hours, then tapering off in severity but continuing for 48 hours. Both were tolerable but uncomfortable. These were very unusual symptoms that were not listed as expected symptoms so I thought they should be reported.

9 minutes after vaccination patient developed chest discomfort with burning sensation and anxiety. BP 151/86 HR 75 RR14 Sat 98% 0.9 % NSS to keep vein open Benadryl 50 mg IV one dose stat

My arm was sore immediately. As the hours progressed after the shot, my left upper arm became very swollen, hard, and painful enough to wake me in the middle of the night. The hard lump was as big & wide as my right hand and began 2 inches above my elbow up to the place of injection. When my morning alarm went off, I was very fuzzy and extremely weak. I was unable to go to work or remember a lock combination I use every day. My energy began to return the next day enough to work a half day but returned to bed for the afternoon. The tiredness was all but gone by 8:30 pm. Reaction began Sunday morning and was gone by Tuesday night.

Extreme pain from top of left shoulder to the elbow. Unable to stretch, scratch my neck, wash my back or put on my seatbelt. The are aches so much that I can not sleep at night. I am unable to lay on my left arm. I have a large hard lump on my left arm at the injection site. Weakness in left hand. Unable to raise my arm to remove my shirt. The pain seems to be getting worse. Left inner leg bruises and pain.

Brain fog and memory loss, since vaccine 1st dose, 04/07/2021 On 04/08/2021 I woke up to find my left eye with filled with blood over most of the sclera. Severe joint pain. Muscle pain, and lethargy. Extremely forgetful with new onset 04/07/2021. Eye pain left eye. L eye hemorrhage is not resolved yet.

pt states after receiving vaccine about one minute after pt states she felt arm tingling and pins and needles feeling in left arm and metallic taste in mouth, and very anxious pt shaking and was unable to sit still in stretcher, refused wheelchair to observation area and ambulated self without difficutly. pt also very guarded and did not want to talk about health history or meds upon assessment. pt state feeling hot and cold chills as well. pt anxious about previous anaphylaxis had in past with darvocet. denies feeling symtpoms of anaphylaxis, site of injection healthy no observed hives or redness in area. vs as noted, pt feeling better and wanting to be sent home pt ambulated to exit with husband at 1438 vs: 1410 bp123/81 hr 84 rr 18 o2 97 1415 bp 140/96 rr 18 hr 78 o2 98 1420 bp 137/80 hr 80 rr 18 o298 1425 131/89 hr 80 rr 18 o2 99

Dizziness, diaphoretic Felt like throat was tight Chest clear, airway clear and was very anxious Benadryl 25mg given by mouth

very bad migraine, nausea, chills, overall very sick feeling, could not get out of bed Took migraine meds & some Tylenol, did not help to counter symptoms and migraine The entire day, starting at 4am, I was unable to get out of bed For the past 1 1/2 weeks I feel very run down and my brain is foggy Will not take a booster vaccine ever! These entire after effects are not worth the taking the vaccine.

I have suffered from tinnitus for a very long time but about a week after receiving the vaccine I woke up to a ramped up ringing in my ears that has not subsided. The noise level increased at minimum 50% and it causes brain fogginess I have not previously experienced.

04/07/21 at 1205 Pt. sitting in Vaccination monitoring area post first dose Pfizer vaccine (lot ER8733); noted to be tearful with hand over chest. Voiced "feels like heat is beating fast all of a sudden". 1207 Pt. moved to monitoring cot into semi - reclined position. 1208 BP 140/82, HR 103, O2 sat 99%, R 20. Skin slightly clammy with no skin redness / rash or throat / tongue edema. 1208 EMS called to site. Pt denies medical hx or any allergies. 1213 Pt. voiced "HR starting to feel better, only notes some lightheadedness / spacey feeling; P 91 / Sat 98%. 1215 BP 132/78, P 65, R 18, Sat 98% - Voiced "thinks everything is okay now; notes only dull ache at right arm injection site. Pt. also called husband to site at time. 1217 EMS arrives and pt. assessed. 1226 EMS provided pt. education on self monitoring & hospital f/u. Pt. declines transport to hospital; will monitor self at home with assist of husband: sitting on side of cot. 1228 EMS departed scene and pt. husband now present; P - 61 and O2 98%. 1229 Pt. and husband voiced readiness to leave. Educated to let pt. PCP know about events post vaccination. Pt. voiced understanding and will just monitor self at home. Both ambulated to from site together

Slight headache, fever (100.4), reduced appetite. It felt like a mild case of the flu. I was allowed to leave work and go home. I slept for a few hours, ate a little bit and went to bed very early (8:45pm). By the next morning, the fever broke and I was fine.

Felt fine until 11 hours after 2nd shot, then felt like I was hit by a truck so went to bed. Could not sleep all night because bones started to ache terribly...felt like my bones were going to explode, which seemed like a very unusual reaction. Halfway through the night, got nauseous. Later in the night got stuffed nose and headache. Woke with headache, body aches, fuzzy head and had fever up to 101.5 all day. Took a Tylenol in the morning and drank a cup of coffee and lots of water which made headache disappear. Finally took a Motrin at 6pm and started feeling much better by 9pm. Slept well. By 7am next morning, was 100% fine albeit tired.

experienced extreme pain on my inner thigh on my left leg; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; It was hot to the touch, very red and swollen; difficulties to sleep and walk; difficulties to sleep and walk; Superficial Thrombophlebitis; This is a spontaneous report from a contactable consumer (patient). A 61 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL9263, expiry date not reported), at the age of 60 years old, via an unspecified route of administration, administered in left arm on 02Feb2021 09:00 at a single dose for covid-19 immunisation. The patient then received the second dose of covid-19 immunisation on 23Feb2021 08:00 AM (lot EN6200), via an unspecified route of administration, administered in the left arm. Medical history included rheumatoid arthritis and multiple sclerosis, both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination and the events. The patient no covid prior to vaccination. The patient's concomitant medications were not reported. The patient was not tested for covid post vaccination. Soon after COVID-19 vaccination, on 21Feb2021, patient experienced extreme pain on inner thigh on left leg. It was hot to the touch, very red and swollen causing difficulties to sleep and walk. Patient then saw a vascular doctor for the pain on 16Mar2021 and was advised that patient have superficial thrombophlebitis (since 21Feb2021) and was prescribed to take Xarelto 15 mg for two weeks. Therapeutic measures were taken as a result of the events reported which included Xarelto 15 mg and had a venous ultrasound of area on an unknown date (unknown results). The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events reported was recovering.

Patient received Pfizer for her first dose on 3/17/21 and a moderna for her second dose on 4/8/21. She states at the 24 hour mark of receiving the moderna she experienced extreme joint pain and swelling. She states she has not been able to work when I called to check on her on 4/13/21.

Abdominal cramp/diarrhea on day of injection and 2 days later 4/17/21, 4/18/21, 4/19/21 Headache and feeling of weakness and foggy head day after injection 41/18/21 subsided by third morning 4/19/21.

Pain in left shoulder/ arm started approximately two hours after vaccine. Pain Consistently getting worse into Wednesday evening to where I was having trouble moving my arm up down behind me a crossed my midsection and out away from my side, pain getting worse intoThursday morning. Called off work Thursday/Friday. Other symptoms subsided after 48 hrs but not the pain in Site area and shoulder. Saturday not improving went to clinic in afternoon.

Shingles-left shoulder blade and left breast (vaccine in left arm); began two days after vaccine with tingling on shoulder blade, then red rash, then painful blisters; stinging/stabbing pain; inability to sleep due to discomfort Lymphadenopathy-swelling in my left breast and chest; much discomfort

Sat (4/17): severe chills for two hours starting at 11:55 pm Sun (4/18): woke and could not walk across the room without falling down due to dizziness, was nauseated, strong headache, fever of 102 all day, bedridden Mon (4/19): Fever was reduced but nausea, headache still persisted all day, continued chills. Right middle finger began to swell and turn purple Tues (4/20): Lost feeling/sensation in right middle finger, head feels off, nausea still persists, stomach pains. Called doctor and had televisit with nurse practitioner

Received the shot about 1:30. Everything was fine. By evening, the arm was sore and left armpit hurt. Went to bed about 10. Woke up about 1:30/2:00 with left arm hurt a lot. Took Advil and went back to bed. Woke up at 4 am to get ready for work and felt awful. Noticed was out of breath on short horizontal walk from bedroom to bathroom, chest tight, acting like an asthma attack. Took a puff of albuterol inhaler and went back to sleep. Got up just before 7, still sore to breath. Grabbed oximeter (being asthmatic, I have one) and noticed )s level down to 94/95 when normally it reads 98/99 on this one. Called allergist to cancel allergy shot scheduled for that morning. Took another puff of albuterol. (Waiting to see if need nebulizer.) Breathing becoming easier and reading now about 97/98 with pulse lower, more normal. Lungs a bit touchy this time of year anyway. And I have had allergic reactions in the past take place as an asthma attack. (For instance, if I eat a small quantity of something with yellow dye 5 in it, I will notice that my breathing is more difficult.)

Tinnitus in both ears, noted the morning after second dose and fairly constant since then (4 days). Loud enough to interfere with sleep at night. I hope it goes away!

DIZZINESS, ATAXIA, WEAKNESS FOR 1 WEEK, THEN DEVELOPED HYPERGLYCEMIA AND DEHYDRATION AND ACUTE DELIRIUM AND HYPERTENSIVE EMERGENCY REQUIRING ICU HOSPITALIZATION

her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little tingling; I have a lot of numbness and tingling in my left side; it's still a little tingling; I had 3 days of sheer misery I couldn't use my left side as I am left handed; it made it kind of difficult; I couldn't hold anything in it, if I wanted to put my hand back; I could not even grab my head up to put it off; I have been not feeling that good; shot I went to home I had gastro intestinal problems; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in arm left (reported as "Left shoulder") on 31Mar2021, at the age of 60-year-old (Batch/Lot number was not reported, it was reported that "it says Pfizer and then 8733") as single dose for covid-19 immunisation. Medical history included multiple sclerosis (MS) and she had the GA (gallbladder atony) thing it was awful she mean anything she ate or drank, right to the toilet. Concomitant medications included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported and Vitamins. Consumer stated, she had the COVID-19 shot last Wednesday 31Mar2021 and she have MS so what it happens was she have got the shot she went to home she had gastro intestinal problems she had she could not get off the toilet for a while and then her MS started to flare, So she have a lot of numbness and tingling in her left side and it's still a little tingling but she had 3 days of sheer misery. She couldn't use her left side as she was left handed so it made it kind of difficult and she live alone. The reporter wanted to know that it was as potential side effects, she was just glad they didn't go full blown affect because they are miserable. When paraphrased the above concern, Consumer stated, No she was starting to get a lot better because she would be really going to say it if it didn't come, because she was not going to stand it but 3 days she couldn't use it at all, she mean she couldn't hold anything in it, if she wanted to put her hand back and probably feel she could not because she was not she could not hold anything she could not even grab her head up to put it off, as she said she had the GA thing it was awful she mean anything she ate or drank, right to the toilet. Consumer stated, No she haven't talked to anybody like any she have been not feeling that good, the first thing she had blown up in because when she had MS it starts to flare she don't she actually want to do is laid down and sleep. For treatment, consumer stated, no treatment, she stayed home, she just rested that's it, it's like her left side is affected her left leg was affected and her arm is affected all the left side is numb and tingly, so she don't like to do anything she don't like to walk anywhere, it's not good. Consumer stated, she just wanted to let us know in case anyone called us with and MS. Date for second shot of COVID-19 Vaccine is "21Apr2021." The outcome of the event "tingling" was recovering; of the other events was unknown. Information about lot/batch number has been requested.

The following morning,, back pain/sciatica began after waking. As the day went on, it got worse. Night-time ... difficult to sleep. Next morning (today) very painful ... difficult to stand (at times) and sit. All similar to my back condition in December that I thought was under control. Taking over the counter medications haven't helped yet. Alternating heat / ice / bacx-brace.

On 4/10/21 I had fever and severe chills. On 4/11/21 the fever broke. I was fine but weak. On the night of 4/11/21 (9:00pm) fever returned. I took advil and went to sleep. On 4/12/21 I woke up with my arm very swollen and it was hot to touch. By the afternoon I was worse and the area was turning red so I went to the Urgent care and diagnosed with Cellulitis (which I have never had and didn't understand at first what this was about). I was treated and returned to my regular Doctor for follow up. I still have this thing and although it's better it's not gone as of this report and it is causing me distress in typing, cleaning and so on.

15 minutes after vaccine, I felt a sudden burning, warm feeling spread through my arms and head. I checked my Watch and heart rate was 127. I had a similar reaction with the first shot on 3/24/21 and was told by staff that it was probably due to hyperventilation and panic after they took my vitals. I did not seek medical attention the second time as the burning sensation disappeared quickly and I was able to lower my heart rate through breathing exercises. I left the medical location about 15-20 minutes after the episode and drove home without incident. I had moderate arm pain and fatigue the rest of the day. On the morning of 4/22/2021, I woke up feeling well except arm pain. At around 7:45 that morning, I had a sudden shaky episode where my watch registered heartrates from 105 up through 153. My hands tingled and they developed a significant tremor. These symptoms are typical for me during a panic attack. I took 1/2 of a Clonazepam and did some breathing exercise and was able to get my heart rate back to normal (in the 70s) within 10 or 15 minutes.

Have had rapid heartbeat, little shortness of breath, blood pressure has been elevated. More severe than normal heartburn, little burning in chest and gallbladder pain. not sleeping well because of it

Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Additional Details: patient said a few days after 1st vaccine she had flu like symptoms: fatigue,brain fog,headache and has not gotten better,also depression,loss of interest in doing things

Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) lump in my throat; turned red on my face and neck and chest and arms; when I get nervous; between my eyes on my forehead felt like a round circle (no bump) (past the bridge above eyebrows). It didn't hurt, but I felt something; felt odd; felt like my eyes were moving back and forth; very very cold; hands were ice cold; This is a spontaneous report received a contactable consumer, the patient. A 60-year-old adult female received the first dose BNT162b2 (solution for injection; batch/lot and expiry information not reported) as a single dose via unspecified route on 14Mar2021 (at 60-years-old), for COVID-19 immunisation. Relevant medical history included high blood pressure, and diabetes. There were no concomitant medications or past drug history reported. The patient reported that she had a couple of reactions the first day, so she was afraid to take the second one. The patient stated that within eight minutes she had a lump in her throat, which she gets when she is nervous and was unsure if from shot or nervousness. The patient reported that then she turned red on her face, neck, chest, and arms. The patient reported that the redness lasted about six or seven hours and did not bother her at all. The patient explained that then between her eyes on her forehead felt like a round circle (no bump) past the bridge above eyebrows. The patient stated that it did not hurt but felt like something. The patient also stated that she felt like she was going to get headache, though did not. The patient reported that it just felt odd. The patient also stated that she felt like her eyes were moving back and forth. Though when she looked in the mirror, they were fine. The patient stated that the eyes happened three times but by the time she looked in the mirror they looked fine. The patient added that she never felt sick or anything though about six or eight hours later she got very very cold which only lasted about a minute. The patient stated that her hands were ice cold and then it all went back to normal. The outcome of the events turned red on my face and neck and chest and arms was recovered on an unspecified date in Mar2021 after 6-7 hours. The outcome of the event she got very very cold was recovered on an unspecified date in Mar2021 after one minute. The outcome of the events hands were ice cold, and felt like my eyes were moving back and forth was recovered on an unspecified date in Mar2021. The outcome of the events, lump in my throat, get nervous, between my eyes on my forehead felt like a round circle (no bump), felt something, and felt odd, was unknown. Information on lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Exactly ONE WEEK after I had the 2nd dose of Pfizer, both my arms began to tingle and hurt by 2 pm on a Monday. Within a few hours, this spread to my entire body; every joint and muscle was in severe pain and discomfort. I went to bed around 5 pm and had the chills, but no fever. I continued with this pain for Monday night and could barely sleep. It continued but not as severe on Tuesday and Wednesday. By Thursday, I forced myself to take a shower. By Thursday, the pain in the upper body was gone, but I still had severe pain in both lower legs from the knees down. It was unbearable if I stood for more than 20 seconds, however, if I lifted each leg and then alternated legs, the pain would go away. This felt like enormous pressure in my legs and at one point, I thought maybe I had blood clots, but my legs were not red or swollen. The lower leg pressure finally went away on its own by Sunday, April 25th, 2021. At no point did I have a fever and I could get some relief by taking Ibuprofen, but not a lot of relief.

her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional instability; head hurts; nauseous; Disorientated; Dizzy; Slurred speech; Balance impaired; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 30Mar2021 17:30 (Lot Number: EW0150; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included depression from 2005 to an unknown date, blood pressure high in 2020 and unknown if ongoing, and high cholesterol in 2020 and unknown if ongoing; stated she was diagnosed with high blood pressure and high cholesterol about a year ago and was on low doses of blood pressure medication and cholesterol medication. There were no concomitant medications. The patient has no prior vaccinations (within 4 weeks). The patient experienced her whole left side, including the left side of her face went numb on 31Mar2021 with outcome of recovering, lost focus on 11Apr2021 with outcome of not recovered, head hurts on 31Mar2021 with outcome of not recovered, nauseous on 31Mar2021 with outcome of not recovered, disorientated on 31Mar2021 with outcome of unknown, dizzy on 31Mar2021 with outcome of not recovered, slurred speech on 31Mar2021 with outcome of recovered in Apr2021, balance impaired on 31Mar2021 with outcome of not recovered, throw up on 10Apr2021 with outcome of recovered on 10Apr2021, emotional instability on 31Mar2021 with outcome of not recovered. The patient received her 1st dose of the Pfizer COVID19 Vaccine on 30Mar2021 and experienced a bucket load of side effects listed with the vaccine. She mentioned that she has lost focus, her head hurts, and so nauseous. She mentioned that half of her face is numb and that she was hospitalized for 24 hours because the doctors thought she had a stroke. She mentioned she has never had a reaction to anything and the doctors told her that this was related to the vaccine. She is asking how long does this side effect last, if the 2nd dose would have more severe side effects than the first, and could she receive her 2nd dose scheduled this Saturday after experiencing this side effects. She mentioned that her doctors recommended that she get vaccinated. She is in distress as she mentioned that this side effects have affected her life and her job. Further clarified, on 31Mar2021 she was disoriented, dizzy, nauseous, and had a massive headache. She said her symptoms were all on the list of possible COVID-19 Vaccine side effects. She said then her (whole) left side, including the left side of her face went numb. She said she called the nurse on the help line, and the nurse told her to call #. She said she didn't call # because she thought it wasn't necessary. She said she went to urgent care. She clarified at the urgent care they flipped out and wheeled her into a back room and hooked her up to a heart monitor, and brain monitor. She said that was around 5:00PM-6:00PM on 31Mar2021. She said she was taken by ambulance from the urgent care to the hospital emergency room. She said she stayed in the hospital overnight. She said she also had slurred speech, couldn't balance, and couldn't track (clarified as focus). She said it was awful. She said they thought she had a stroke because the left side of her face, and her whole left side were numb. She said if she tried to smile, one side of her face didn't work like other side of her face. She said when she was at the hospital, the hospital did all kinds of tests on her. She said she was told she didn't have a stroke, and her symptoms had to be a side effect of the COVID-19 Vaccine shot. She said the doctors at the hospital told her to "tough it out", and wait until her symptoms were done. She said the numbness was gradually going away on the left side of her body. She said the left side of her face was partially numb, and she had parts of left arm that were still numb. She said Thursday, 08Apr2021, was the first day she felt good. She said she was able to focus, and work. She said she felt she had a steady focus, and was not losing her mind. Friday morning (09Apr2021) was "iffy", but she felt she had improved some during the day. She said by Friday night (09Apr2021), she was dizzy, had a headache, was nauseous, and her balance was off. She said on Saturday morning (10Apr2021), she was nauseous, and started throwing up. She said she continued to throw up until Saturday night (10Apr2021). She said she was still nauseous on Saturday night, but was able to have soda crackers. She said she felt like she was standing at a cliff, because she was still nauseous, but not throwing up. She said Sunday morning (11Apr2021) she was not great. She clarified she was still nauseous, had a headache, was constantly dizzy, and lightheaded. She said she didn't throw up, but her focus kept coming and going. She said she felt worse as Sunday night (11Apr2021) came on. She said today (12Apr2021), she was so nauseous, her head hurts, she was dizzy, and couldn't track (focus) well. She clarified she never had a fever with her other symptoms. Caller asked what the hell was going on, and why was it still happening, and how long were her symptoms going to last. She said she was scheduled to get her second COVID-19 Vaccine shot on Saturday (17Apr2021). Caller asked should she get the second COVID-19 Vaccine shot. Reported also had emotional instability from day one (31Mar2021) of her symptoms. Reported she had been resting for a half hour at a time. She said she would feel better for a period of time after resting, so the resting helped. She said she also took Ibuprofen and Tylenol (clarified as generic (place name withheld) Acetaminophen 500mg). She said the Ibuprofen and Acetaminophen helped to keep her headache in the background. Hospital Treatment: She said while she was at the hospital, she was given Aspirin and Tylenol because of her headache. She said the doctors at the hospital didn't change her home medications. The patient underwent lab tests and procedures which included blood test: normal on 01Apr2021, head CT (computerised tomogram): normal on 31Mar2021, echocardiogram: normal on 01Apr2021, tests: unknown results on an unspecified date (the hospital did all kinds of tests on her), MRI brain (magnetic resonance imaging): normal on 31Mar2021, carotid artery ultrasound: normal on 01Apr2021. Therapeutic measures were taken as a result of head hurts (headache). Reporter seriousness for her whole left side, including the left side of her face went numb: hospitalization from 31Mar2021 to 01Apr2021, required a visit to Emergency Room and Physician Office/Urgent Care.

This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.

Extremely confused and agitated. Vision was reduced significantly. Not able to understand or comprehend simple tasks. This went on for 3 days.

delirium; chills; fever; headache; body aches; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 13Apr2021 10:00 (at the age of 60-years-old) as single dose for COVID-19 immunisation. The patient took the first dose on 23Mar2021 at 10:00. The patient's medical history and concomitant medications were not reported. On 13Apr2021 at 22:00, about 12 hours after receiving the 2nd dose, the patient experienced chills, fever, delirium, headache, and body aches. By 35 hours after the dose, symptoms were mostly past. The patient did not have COVID prior vaccination and patient was not tested post vaccination. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Cardiac Arrest at 1:30 pm on 4/30/2021. . Arrest was witnessed by family and Emergency Medical Personnel. Cardiopulmonary Resuscitation was initiated. Pt was very anxious when EMS arrived.

Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Dizzy; Fatigue; Energy decreased; not feeling as much energy as before; Pain upon movement; walk about a block but then starts to hurt; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program, based on the information received by Pfizer (Manufacturer Control No: 21K-163-3774842-00). Solicited report from a consumer of a 60 year old female with events of heart/atrial flutter, atrial fibrillation, eye surgery and arm surgery and non-serious weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt with humira 40mg/0.4ml (adalimumab). The patient had a relevant medical history of tobacco use/four cigarette sticks per day, seropositive high titer rheumatoid arthritis, fingers swelling, joint pain, joint swelling and lost of blood flow in hands and legs. On unknown dates, the patient experienced eye surgery, arm surgery, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt. In 2020, the patient experienced heart/atrial flutter and atrial fibrillation. In Sep2020, the patient experienced weight gain due to attempting to stop smoking. On 24Feb2021, the heart/atrial flutter and atrial fibrillation resolved. Covid-19 vaccine was also considered suspect. The patient had eye and arm surgery in the past. On 24Feb2021, she underwent pulmonary vein cryoballoon ablation surgery for the atrial fibrillation and atrial flutter. She had a procedure done and went into her heart and froze the nerve endings that were causing the atrial fibrillation, and also fixed the flutter in her heart. The causality as per reporter for this procedure was reported as no reasonable possibility. She still recovering. She discontinued the Humira two weeks before the surgery and took her last injection on 10Feb2021 and was paused it for four weeks, but she started back it on 10Mar2021. She follows up with her surgeon at the end of the month and she hopes this helps got her off of the blood thinners and other medicines, she been on for this. She stated that this was not related Humira. She was advised by her physician to increase the exercise to lose some weight. With her lower back issues, she was hoping that when she got off of the blood thinners, she could do pain shots again and start exercise. She could walk about a block but then she started to hurt. She had been careful with her diet also, cut out the salt also. This had nothing to do with Humira and she did not want to be contacted about this again for this also. She felt fuzzy, it took her most of the morning to get woken up. Her Doctor thinks once she would off of the blood thinners she would be back to normal. Other than that she feels fine. She does not wanted to be contacted about this. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received first dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown. She agreed to have physician contacted. Blood thinner was also considered as co-suspect. Other medical history included abstains from alcohol, contrast dyes allergy manifested by scratch throat, allergy manifested by bowel movements (oral medications for rheumatoid arthritis; up to eight times a day and slept 15 hours per), prevent esophagus damage, heart, low thyroid, and attention-deficit/hyperactivity disorder. The patient's concomitant medications included pantoprazole to prevent esophagus damage, metoprolol for heart, levothyroxine for low thyroid, vortioxetine hydrobromide (TRINTELLIX) for depression, and dexamfetamine sulfate (DEXTROAMPHETAMINE) for attention-deficit/hyperactivity disorder. The patient underwent laboratory tests and procedures which included blood work: everything was fine in Jan2021; chemical stress test and treadmill stress test: confirmed atrial fibrillation and atrial flutter in Sep2020; body weight: gain in Sep2020; and X-ray: confirmed atrial fibrillation in Sep2020. The action taken in response to the events for adalimumab and apixaban was unknown. The patient recovered from atrial flutter and atrial fibrillation on 24Feb2021. Outcome of Feeling abnormal and Pain upon movement was unknown. The patient had not recovered from the remaining events. Change History: On 05Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, past drug information, laboratory/diagnostic procedures and narrative description. The events of "atrial flutter", "atrial fibrillation" and "weight gain due to attempting to stop smoking" were added. On 11Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "LOWER BACK ISSUES" and "WALK ABOUT A BLOCK BUT THEN STARTS TO HURT" were added. the event of "atrial flutter" was amended to "heart/atrial flutter". On 08Apr2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "felt fuzzy", "got first dosage of covid-19 vaccine and experienced sore arm", "fatigue and dizzy from the blood thinners after surgery" and "still not feeling as much energy as before" were added. Causality for humira 40mg/0.4ml(adalimumab): The reporter's causality for the event(s) of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood THINNERS after surgery unknown onset and fatigue and dizzy from the blood thinners after surgery unknown onset with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of felt fuzzy, still not feeling as much energy as before and walk about a block but then starts to hurt was not provided. Manufacturer opinion is that there is no reasonable possibility that the events of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery unknown onset, fatigue and dizzy from the blood thinners after surgery unknown onset, still not feeling as much energy as before and walk about a block but then starts to hurt are related to humira 40mg/0.4ml(adalimumab). The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information , the events of sore arm, fatigue and dizzy could be related to the suspected drug of BNT162B2. The other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.

Patient tested positive for COVID on April 12th after having received both COVID-19 vaccines - pfizer. Patient has known COVID19 exposure from her son and was COVID19 positive in April. The patient had a positive asymptomatic COVID-19 test. Patient was tested prior to planned colonoscopy. The patient completed 10 days of quarantine until April 22. Patient presented to hospital (sister hospital) on May 2nd after 1 week of fevers and productive cough. At MSQ patient received cefepime/vancomycin/doxycycline for CAP. She initially improved, but on 5/5 she had recurrent fever with rapid decline, her respiratory status requiring 2L of NC to HFNC to NRB. CXR with B/L opacifications. CTA chest was negative for PE, but patient with diffuse groundglass and consolidative opacities. Also had TTE that showed LVEF 71% and grade 1 diastolic dysfunction. She was evaluated by MSQ Infectious Diseases physician and was started on bactrim for PCP prophylaxis and resumed on broad spectrum antibiotics. She was also evaluated by rheum in sitting of her SLE and patient was started on prednisone 40 mg q8h methylprednisolone for potential SLE flare. Continued on cefepime and vancomycin. Patient was transferred to Hospital due to worsening respiratory status and tested positive for COVID-19 at MSH on 5/9. Admitted to the MICU, patient received a loading dose and one 100 mg dose of remdesivir - stopped due to elevated liver enzymes. On 5/16 extensive new ischemic/hemorrhagic strokes throughout intracranial vascular distribution, DIC d/t COVID vs AF and intubated for mental status changes. Patient's clinical picture worsening - requiring pressors. Chest x-ray with diffuse ground glass opacities, ARDs and pulmonary edema. Patient remains in critical condition in MICU as of 5/19.

incredible chest pressure; shortness of breath; anxiety; chest started hurting; pain across her breasts; concentration levels are off; but being that sick makes her so weary.; She goes to the bathroom 12 times a night to urinate; body aches; feet hurt/top of her feet hurt really super bad/legs hurt; pressing under her arm and she had pain really bad there; pain went around her back /whole back started hurting; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in right arm on 27Apr2021 (Batch/Lot Number: ER8731) as single dose for COVID-19 immunisation. Medical history included ongoing congestive heart failure, diabetes, high cholesterol and high blood pressure. Concomitant medication(s) included aripiprazole (ABILIFY) taken for an unspecified indication, start and stop date were not reported; atorvastatin calcium (ATORVASTATIN CALCIUM) taken for an unspecified indication, start and stop date were not reported, noted as on of the 2 new heart medication; and another unspecified heart medication. No other vaccine within 4 weeks. The patient received the first dose of the COVID-19 vaccine on 27Apr2021, then 2 days later on 29Apr2021 she developed side effects of body aches and couldn't get comfortable sitting, laying down, or standing, and her feet hurt, the top of her feet hurt really super bad and her legs hurt. She stated she was feeling "fair to partly cloudy" and "this is just beyond anything". She stated she literally didn't want to exist anymore the pain was that horrible, that when she was experiencing adverse effects she couldn't get comfortable in any way, nowhere to go, nothing to do, no warm bath, no hot warm or cool compresses, it was just her whole body. She said there was nothing that would help and she just didn't know if she could do that again. She only had relief through paracetamol (TYLENOL) and she took so much that she felt her liver was in jeopardy. She stated it was a really bad experience. The patient was also having incredible chest pressure and shortness of breath, onset date unspecified. She had a diagnosis of heart failure/a history of congestive heart failure, with the body aches she was having, she thought she was going into heart failure. She did call an ambulance twice (maybe 29Apr2021 then 01May2021; she didn't remember exactly which days) and the emergency medical technicians (EMT) took an EKG each time. The first time she called the ambulance the EMT's offered to take her to the hospital. Her EKG did look abnormal but it could have been attributed to her history of heart related issues or anxiety. The second time her chest started hurting it was hard to distinguish between pain and pressure. There was definitely pressure. There was also pain across her breasts (onset date unspecified) and underneath her arm (on 29Apr2021; initially she was pressing under her arm and she had pain really bad there), she was questioning her lymph nodes. Then the pain went around her back and then her whole back started hurting and her whole body was hurting, onset date 29Apr2021. She had never experienced anything like this before, as stated. She also reported that her concentration levels were off (onset date unspecified). She couldn't listen to music or do anything like that. She spoke with her doctor but being that sick made her so weary (onset date unspecified). The patient reported she didn't know if her symptoms were because of the COVID-19 vaccine or because of her new heart medication, but she said it's stupid to think her symptoms could be caused from her new pills. Her doctor wanted blood work on 27Apr2021 primarily because of all the medical diseases she had. She's guessing maybe blood work would give her an indication of why the vaccine made her feel the way it did. She went on 05May2021 to get bloodwork. She went to the bathroom 12 times a night to urinate (onset date unspecified) and she asked her doctor to put her on Lasix so she could just get the urine out. The doctor told her that her heart and her lungs sound good. The patient asked if she should still get the second dose of the vaccine as she was worried that the symptoms could be worse after the second dose. She was supposed to return for her second COVID-19 vaccine on 14May2021, but she was not going (though she knew she needed to get the second dose), she did not want to get it. The events body aches, feet hurting/legs hurting, pain underneath her arm, back pain, were ongoing but lessened in severity. As of the time of reporting, she had started to feel better, these events (body aches, feet hurting/legs hurting, pain underneath her arm, back pain) were resolving. The outcome of the other events was unknown.

An hour after vaccination, it hurt around my heart and for 3 days there was pain in my collar bone on the left side, a lot of heart burn or air bubbles in my chest also, and now I'm scared to get the 2nd dose and I've not felt right since.

At 6:00 a.m. on May 23, 2022, the 9th day after my 2nd dose of the Pfizer COVID-19 vaccine I stood up and became so dizzy I feel head-first into a chair next to the place I was standing. Since that time I have experienced extreme vertigo (for the first time in my entire life I have never been dizzy in my life, at all). I can?t lay on my left side because I can?t turn my head to the left. I can?t drive because I can?t turn my head to the left. When I do, my head becomes swimmingly dizzy. It is an extreme dizziness. Not just lightheaded. Also I cannot lean my head backward to look up because I experience the same thing. I have joined a website for COVID-19 Vertigo side effects in order to get information or ideas as to what I can do and when I can hope for relief.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild

Vaccine given in the afternoon of 1/16, a Saturday. By Sunday am on the 17th, the hearing was gone in my right ear. Got into the ENT doctor on Monday the 18th. Had an exam and hearing test. Started high dose of steroids on 1/19. Had to be out of work for 1 month. About 80% ish of the hearing returned in that ear. Had 1 steroid injection into ear drum of that ear. Throughout the month, had many ENT appointments and hearing tests. Hyperbaric chamber was recommended by the dr. But my insurance would not cover it.

feeling tired; mild heart increase; mild heart palpitations; chills; feeling bad; low-grade fever of 100; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EL9264) via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:45 (at the age of 60-years-old) as single dose for covid-19 immunisation. The patient's medical history includes history of colon cancer, anaemia, hypertension and asthma and drug hypersensitivity. The patient previously known allergies includes: Sulfa, EES, Augmentin, oxycodone, vancomycin, duramorph. The patient's concomitant medications included budesonide, formoterol fumarate, glycopyrronium bromide (BREZTRI AEROSPHERE), hctz, meloxicam and zolpidem tartrate (AMBIEN). It was reported that on 02Feb2021, at 08: 45 AM initially within five minutes after the vaccine, the patient felt mild heart palpitations with mild heart increase. She monitored on her (company name) watch heart rate, ECG and oxygenation level. This resolved within 15 minutes. During the day following she started having chills just generalized feeling bad. Had a low-grade fever of 100 last evening. This morning feeling tired on 03Feb2021. The outcome of the events was recovering. Therapeutic measures were not taken by the patient for resolving of the events. Follow-up attempts are completed. No further information is expected.

shot entry is the size of an apple; heart palpitations; diarrhea; blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips; Because of the blisters she had a hard time breathing and couldn't can't eat; had a fever of 102°F; weak; tooth throbbing; body aches; food tasted like crap for anything that she could get into there; Because of the blisters she had a hard time breathing and couldn't can't eat; Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling; injection arm was "swollen so bad" from her neck to her fingertips; vomiting; lightheaded, dizziness; Migraine headache/migraine; her arms swollen down to her fingertips which she could not sleep on her left side; could not get out of bed; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot Number: EWO182) as single dose for COVID-19 immunisation. Medical history included allergic reaction to back yard tree and had sniffles and watery eyes prior to shot. There were no concomitant medications. The patient received her first Pfizer Covid vaccine dose on 18May2021. That evening she began to experience side effects. Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling. She had Migraine headache and vomiting. At 5 AM the following day 19May2021, she was vomiting, had diarrhea, a migraine, and then developed blisters in her mouth. Because of the blisters she had a hard time breathing and couldn't can't eat, had a fever of 102 degree F, was feeling weak, had to crawl to bathroom. She reported that 24May2021, was the first day that she felt ok. It was reported that her arms swollen down to her fingertips which she could not sleep on her left side, blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips, stated that she could not go to her dentist appointment the following day because of blisters and her tooth was throbbing on 19May2021. Stated that she had migraine headaches with vomiting, diarrhea, heart palpitations, weak, 102 fever, food tasted like crap for anything that she could get into there. The patient is supposed to go on 08Jun2021 for her second shot and was told that the second is worst than the first. Stated that she refused second shot. Stated that she could not get out of bed. Stated that she has a 7 and 8 year old to take care of by herself. Stated that the shot entry is the size of an apple on 24May2021. Clarified that she had the shot in her left arm. Caller stated that she had the Covid shot 18May2021 and she still does feel well today. Clarified that the blisters all started at the same time. Stated that she has had no heart palpitations since 5am this morning (24May2021). Stated that her fever is 99.9 Caller keeps rambling on; unable to clarify details with each event. Stated that the migraine is now a headache. She wants to know what would happen if she doesn't get the second dose of the vaccine. The patient received no treatment. Outcome of the events could not sleep on her left side, could not get out of bed was unknown; peripheral swelling was recovered with sequelae on 23May2021, vomiting was recovered with sequelae on 24May2021; Heart palpitations was recovered on 24May2021; Fever, migraine, couldn't lift up her arm, hard time breathing was recovering; all other events was not recovered. Follow up attempts needed. Further information is expected

The caller's heart was really fast and heart pressure went up; has been experiencing runny nose, has the flu; has been experiencing runny nose, has the flu; Only pain on arm for two or three days; got a panic; got a panic; The caller's heart was really fast and heart pressure went up; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0182) via an unspecified route of administration in right arm on 10May2021 at 11:30 (age at vaccination 60-year-old) at single dose for covid-19 immunisation. Medical history included tachycardia from 12Apr2021 and ongoing, transient global amnesia from 25Mar2021 and ongoing, anxiety from 25Mar2021 to an unknown date, panic reaction from 25Mar2021 to an unknown date, amnesia from 25Mar2021 to an unknown date. Concomitant medication included cannabidiol (CANNABIDIOL) taken as needed for amnesia from 28Mar2021. The patient is not taking the CBD oil right now, only takes when needed. Has not taken in two weeks, was not she should take it. Suspended for four or five days before first dose. Really does not need it. No other vaccine in four weeks. On 26May2021, patient experienced runny nose, on 25May2021 patient experienced flu like symptoms, on 10May2021 patient got a panic after receiving the first dose Pfizer Covid Vaccine on, the caller got a panic and had to stay at the vaccine facility for half an hour. The patient's heart was fast and heart pressure went up. The patient stayed at the vaccine facility like thirty minutes after receiving the first dose Pfizer Covid Vaccine. The patient stated this went away. The patient knew every time she has anxiety her heart goes up, it is something that happens. The patient let the persons know at the vaccination facility it is not the Pfizer Covid Vaccine, because the patient has that problem right now. Patient's heart was fast and heart pressure went on, on 11May2021 patient experienced pain on arm for two or more days. Patient also experienced cardiac discomfort. The patient stated that the side effects were only pain on arm for two or three days and this began on 11May2021, the day after receiving the first dose Pfizer Covid Vaccine. The patient is experiencing a runny nose right now had the flu but doesn't have any high temperature. The patient states she does not speak English that well HCP: the caller does not wish to provide name, address, telephone number or email. The physician stated she doesn't have a primary care physician yet. The patient was experiencing a runny nose right now began on 26May2021 and is persisting. Had the flu but doesn't have any high temperature: The patient states this began on 25May2021 is ongoing and is improving a little bit. The patient states she is taking CBD oil because she had an issue back on 25Mar2021 of amnesia. The patient has tachycardia and has issues with anxiety and panic. The patient stated after receiving the first dose Pfizer Covid Vaccine on 10May2021, the caller got a panic and had to stay that the vaccine facility for half an hour. The caller's heart was really fast and heart pressure went up. The caller stayed at the vaccine facility like thirty minutes after receiving the first dose Pfizer Covid Vaccine. The caller states this went away. The caller knows every time she has anxiety her heart goes up, it is something that happens. The patient let the persons know at the vaccination facility it is not the Pfizer Covid Vaccine, because the caller has that problem right now. The caller states this went away in thirty minutes. Anxiety and panic not diagnosed, she can just feel it. This started after problem of amnesia the caller had on 25Mar2021. Transient Global Amnesia, had a problem of amnesia on 25Mar021. The patient is not taking the CBD oil right now, only takes when needed. Hasn't taken in two week, wasn't she should take it. Suspended for four or five days before first dose. Really doesn't need it. The patient received the first dose Pfizer Covid Vaccine on 10May2021 and is scheduled for the second dose on 31May2021. The patient has a runny nose right now and had the flu. The caller is asking if they should get a Covid test prior to receiving the second dose Pfizer Covid Vaccine. Only pain on arm for two or three days The patient states the side effects were only pain on arm for two or three days began on 11May2021, the day after receiving the first dose Pfizer Covid Vaccine. She has recovered from the arm and everything. The patient mentioned she was scheduled to receive the second dose Pfizer Covid Vaccine next Monday, 31May2021. Patient did not undergo lab tests and procedures. The outcome of event was recovered in 2021. Information on Lot/Batch number was available. Additional information has been requested.

soreness on her arm/ sore arm; felt very cold; weird sensation which she can't fully explain. It was like electrical impulses all over her body started appearing and like her blood is running inside all over her body; heart rate went a little fast, recorded at 110-112; could not sleep; This is a spontaneous report from a contactable Nurse. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 01Mar2021 (Batch/Lot Number: EN6205; Expiration Date: Jun2021) as 1st dose, single dose for covid-19 immunisation. Medical history included covid-19 from 27Nov2020 to an unknown date and aggressive fever. The patient's concomitant medications were not reported. The patient previously took albuterol, tylenol and mucinex for covid-19. The patient reported that she was fine after 1st dose of the Pfizer vaccine but experienced some soreness on her arm and took tylenol. When she got home, she felt very cold but did not have a fever and had a normal temperature. As she was laying down, she felt a weird sensation which she can't fully explain. It was like electrical impulses all over her body started appearing and like her blood is running inside all over her body. Her heart rate went a little fast, recorded at 110-112 while her normal is 100-110. She could not sleep because of this. She woke up today and mentioned that her symptoms are lessening, not as intense as they were last night, and there is a little improvement. She took Tylenol for her symptoms and did not go to work. She received the vaccine amidst having a previous COVID Diagnosis last thanksgiving, 27Nov2020 and stated that she may still have antibodies from her infection and that the vaccine might be interacting with it. She knew that the Pfizer vaccine was not tested in people with previous COVID Diagnosis and just followed the CDC's recommendation to get vaccinated after 90 days after the infection and inquired for information, Pfizer may have on these topics and if she should receive the 2nd dose on 22Mar2021. She had covid around thanksgiving being about 3 months ago, so she waited the 90 days to get the vaccine. She reported that since she was a covid patient, she was thinking is it because she had antibodies. She was checked 2 weeks in Feb2021 and she was positive for antibodies and wanted to know the relationship between antibodies and the vaccine. Therapeutic measures were taken as a result of soreness on her arm/ sore arm. The patient underwent lab tests and procedures which included heart rate: 110-112, heart rate went a little fast, recorded at 110-112 while her normal is 100-110, sars-cov-2 antibody test: positive on Feb2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

needle was put in and burned like hell and her head kind of exploded; arm was throbbing; pain rotated out everywhere after 30 minutes; burn a little regarding; incapacitated; injection site swelled and turned red; injection site swelled and turned red; non-anaphylactic reaction; nightmare; Bruise; This is a spontaneous report from a contactable consumer (patient). A 60-year-old (age at vaccination) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 22Feb2021 (lot number: EN6198; expiration date: 30Jun2021) as 1st dose, single, dose 2 via an unspecified route of administration on 15Mar2021 (lot number: EN6204; expiration date: 30Jun2021) as 2nd dose, single for COVID-19 immunisation and varicella zoster vaccine rge (cho) (SHINGRIX), via an unspecified route of administration, administered in left deltoid on 01May2021 (lot number was 9NH54 and expiration date was 14Oct2022), at an unknown, single dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient family history included shingles (caller mother had shingles). On an unspecified date, the patient experienced needle was put in and burned like hell and her head kind of exploded, arm was throbbing, pain rotated out everywhere after 30 minutes, burn a little regarding, incapacitated, injection site swelled and turned red and non-anaphylactic reaction. The clinical course of the event was reported as: caller stated that her pharmacist told her to report because she had Shingrix vaccine injection on 01May2021 and had a non-anaphylactic reaction but her reaction was epic and her pharmacist said that the company would want to know this information for the numbers related to the product. It was reported that her weight was when she was fully dressed. The caller stated for Shingrix vaccine, the needle was put in and burned like hell and her head kind of exploded and that was epic. The nurse said it did burn a little regarding the patient stating Shingrix vaccine burned upon administration; stated the nurse let her go but she wanted to stay in the store for a few minutes and it felt really awkward; her head settled down and her arm was throbbing and started screaming; stated the pain began in her lower back and her arm, head and right side of her hip and moved throughout her body and the pain rotated out everywhere after 30 minutes the pain settled down and she just had the pain in her arm. She stated the area where Shingrix was injected was almost like a baseball sized circle and was read and she had to drive to care for her parents and that made this a nightmare. She removed the band aid from the injection site because the band aid caused a bruise and the injection site swelled and she remembers taking the band aid off and not being able to put ice on it and could not bear the pain. She could not put ice or clothes on top of the injection site and could not take it. She reported her head was just killing her and it was ridiculous to had to use that arm and to lift it like a disabled arm, she would say she was incapacitated and only if forced could she do something under those conditions. She stated the injection site swelled and turned red and just continued to swell, turn red and was burning and hurting and did not go farther and was the size of a baseball. She reported that the other symptom was she had her head back down and no pain in her back anymore, no pain in her chest anymore, and no pain in her legs anymore. She stated the pain after Shingrix vaccine was localized but gave her a headache; states using that arm was insane and if she was not forced to use the arm she could not use it effectively and this was not an anaphylactic reaction and the reaction was not moving anywhere else; stated the area of the injection site is now black all around it like the nurse gave a bad vaccine but she did not do a bad job; stated she could see the dot where the Shingrix vaccine went in. Stated the indication for which she had Shingrix vaccine was that her mother had shown up with shingles and they took her to the emergency room on Sunday (as reported) with a rash that began to bubble so the caller called for her mother; stated her mother was transported to the hospital and the caller had been wearing gloves and thought it was contagious and it was shingles; states the six doctors for her mother in the ER pressed the caller to get Shingrix vaccine. Caller stated the reported reaction for Shingrix vaccine lasted 11 days and sort of calmed down and all she could see now was the red dot where the vaccine was administered; stated she was sure she would have to do Shingrix again due to her reaction and did not have an anaphylactic reaction but wanted to report this as she was told. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

60-year-old Female was found by EMT sitting upright and complaining of being lightheaded. Client was alert and tracking with her eyes while nervous. Client had a chief complaint of anxiety post vaccination. Client stated she began to feel anxious shortly after her vaccination and requested to lie down for the duration of her observation. Client has a history of anxiety for which she is taking CBD oil. Client also has a history of new onset tachycardia and periodic irregular heart rate for which she sees a cardiologist. Client was recently diagnosed with transient amnesia. She denies any allergies. Assessment revealed no swelling, hives, discoloration, shortness of breath or other signs of anaphylaxis. Airway, breathing, and circulation were intact. Client denied any pain throughout her body. Client's initial vitals were a heart rate of 76 and irregular, blood pressure 160/98, respirations 20 and regular, alert and oriented to person, place, date and event, eyes equal and reactive to light, lung sounds clear bilaterally and SPO2 100% on room air. Client was shaking while anxious but consolable. Client consented to an additional 30-minute observation after her first set of vitals. She was provided water during her observation. Her remaining vitals at 1152 - 158/98, pulse 86, O2 99% respirations 16. After approximately 5 minutes, client reported that she felt much "better" and remained calm for the rest of her observation. Client's vitals improved at the completion of her observation with a heart rate of 80 and regular, respirations 16, blood pressure 140/88 and O2 98%.. Client departed vaccination site after 30mins of observation feeling "better".

She could not sleep the whole night; Right hand is swollen; She has a sprained wrist; Her hand, that is somewhat in pain from the sprain, and is most of the time fine, was in; Her left knee was hurting her a lot worse; Sore arm; First dose: sore arm; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6206) via an unspecified route of administration (age at vaccination 60-year) in Left Arm on 09Mar2021 as single dose for COVID-19 immunization. Medical history included accident (The accident was 25 years ago, and they told her that she had shrunk an inch from the accident. It is hard for her to say) and cardiac disorder (Her dad has heart disease) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 09Mar2021 the patient experienced sore arm after receiving first dose; On 30Mar2021 her hand, that is somewhat in pain from the sprain, and is most of the time fine, was in; her left knee was hurting her a lot worse; sore arm; her right hand is swollen and she has a sprained wrist. On 30Mar2021 09:30 she reported she could not sleep the whole night. The seriousness of all the event was reported as non-serious. Her left knee was hurting her a lot worse was recovering. The clinical outcome for all other events was unknown. No follow-up attempts are needed. No further information is expected.

Right away the vaccine made my arm tingle and it was painful. I woke up that morning and I had chills and I felt very nausea. I had body aches and I was breaking out into sweats. I took some Tylenol , I had a headache. The nausea was very horrible, and I didn't have much dizziness. The brain fog is the worst thing that I have experienced. I have severe brain fog . I have no appetite and certain smells will bother me and make me more nausea. When I am sitting still , I feel a dizziness where I feel like I am seeing stars. After the vaccine I wasn't able to keep up anything not even ginger ale or water.

vomiting; fever; chills; diarrhea; dizzy and shaky; dizzy and shaky; she "felt [her] gut and pieces of tissues from [her] gut were coming out; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 01Jun2021 (at the age of 60-year-old) as single dose for COVID-19 immunization. Patient medical history included COVID-19 in Nov2020 and long haulers before getting the vaccine. Concomitant medications were not reported. On an unspecified date in Jun2021, after receiving first dose of vaccine, patient experienced violent vomiting, fever at 101.9F, chills, diarrhea, felt dizzy and shaky. Patient explained she was sitting on the bowl, had diarrhea, and had her "head in a bucket" but the force at which she was vomiting was unbelievable. Patient described she felt [her] gut and pieces of tissues from [her] gut were coming out; and the content sprayed on her walls, even 6 feet away reaching the shower. Patient specified she didn't vomit when she was infected with COVID-19. Patient explained that she feels better this morning but would like to know if she was contagious. Patient asked if she should quarantine for 14 days after experiencing side effects from the Pfizer-BIoNTech COVID-19 vaccine. Outcome of the events was unknown. Information about lot/batch no has been requested.

Forgetting where I parked car; not getting everything I went to the store for. Burning food on stove.; patient took 1st and 2nd dose both on 02Apr2021; This is a spontaneous report received from a contactable consumer or other non hcp (patient). A 60-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0150, expiration date not reported), via an unspecified route of administration in left arm on 02Apr2021 10:30 (age at vaccination 60years old) as 1st dose, single dose for covid-19 immunisation. Reportedly, same day patient was administered second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0167, expiration date not reported) via an unspecified route of administration in right arm on 02Apr2021 as 2nd dose, single dose for covid-19 immunisation. The most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Medical history included fibromyalgia, allergies to tannins from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On 27May2021 11:30 the patient experienced forgetting where he parked car, not getting everything he went to the store for and burning food on stove. The patient did not receive any treatment for the adverse events. The case was assessed as non-serious as per the reporter. The clinical outcome of the event was unknown. No follow up attempts are possible. No further information is expected.

really bad flare up of rheumatoid arthritis; she had a fever of 101.5 degrees Fahrenheit; she had chills; After her second COVID-19 Vaccine, she had a headache; After her second COVID-19 Vaccine, she was tired; her hands and feet got real swollen; She said she hadn't felt right; hadn't felt right; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 60-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0162) via an unspecified route of administration in left arm on 23Mar2021 between 17:20-17:30 as 1st dose, single dose for COVID-19 immunization. Medical history included ongoing rheumatoid arthritis (from 2003), she has had rheumatoid arthritis for almost 20 years. Concomitant medication included Xeljanz XR 11mg. On 24Mar2021, patient had fever of 101.5 degrees Fahrenheit, chills, headache, she was tired. On an unspecified date in Mar2021, her hands and feet got real swollen, she had not felt right since she had COVID-19 Vaccine. It was reported that patient received her second shot of Pfizer (COVID-19) Vaccine on 13Apr2021 and experienced really bad flare up of rheumatoid arthritis in Apr2021. The patient stated she got both doses of the Pfizer (COVID-19) Vaccine, and after her second (COVID-19) Vaccine, she had a really bad flare up of rheumatoid arthritis. The patient stated her doctor put her on Prednisone for 2 weeks. Reported she had received her second COVID-19 Vaccine dose right before her 61st birthday. She said she went to her rheumatologist, and her rheumatologist told her she should report her side effects to Pfizer. She said she already reported her COVID-19 Vaccine side effects on V-Safe. Patient took 1 Tylenol (8HR Arthritis Pain Extended Release 650mg, Lot Number: LPA095, Expiration Date: Aug2020) for a fever of 101.5 degrees Fahrenheit. She said the Tylenol helped her fever, providing. Reported the Tylenol 8HR Arthritis Pain Extended Release 650mg was expired, but the product still worked. Patient stated for Rheumatoid Arthritis Flare Up, her rheumatologist prescribed 1 Prednisone 5mg tablet, once a day, for 2 weeks. She said she saw her rheumatologist on 17May2021. She said she completed her Prednisone 5mg prescription, and the Prednisone 5mg tablets were dispensed in a pharmacy bottle, and she didn't have the Prednisone 5mg NDC, Lot, and Expiration Date. Reported she was feeling better now, but wanted to report her Pfizer BioNTech COVID-19 Vaccine side effects to Pfizer, so she could help other people with rheumatoid arthritis. Reported she continued to take her Xeljanz XR 11mg while she took the Prednisone 5mg tablets, providing the Xeljanz XR 11mg (NDC Number: 0069-0501-30, LOT Number: DJ2906, Expiration Date: 31May2022). Reported she was feeling better now, but she was not 100%. She said she could actually walk now. She said she still had swelling in her hands and feet. She said the swelling had improved in her hands, saying she could make a fist now, but she couldn't wear her wedding ring. She her sandals still felt tight on her feet. Reported she was very reluctant to get a COVID-19 Vaccine booster shot in 12 months with her auto immune disease. She said she was not going to get the COVID-19 Vaccine booster, if she was going to have the same reaction she had after her second COVID-19 Vaccine dose. Patient asked if Pfizer had done any studies with people who had rheumatoid arthritis and the COVID-19 Vaccine. The outcome of the event fever, chills, headache was recovered on 25Mar2021 and outcome of the other events was recovering. Follow up attempts are needed. Further information has been requested.

About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, feeling that I would pass out, lightheafdedness, increased heart rate and blood pressure, mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness, very slight throat soft tissue sensation

Headache, fever, chills, cough, congestion, malaise, patient reports she has been "down" since Saturday and is still experiencing all of these symptoms overall. Patient has been taking TheraFlu

aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was freezing/chills; cold was worse; couldn't get comfortable; started feeling bad when she went to bed; This is a spontaneous report from a contactable consumer (patient's husband). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 27Dec2020 at 12:45 on Left Upper Arm at single dose for COVID-19 immunization in hospital. No additional vaccines administered on same date of bnt162b2. The patient medical history included she may be a little overweight, but she was not obese. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium (SYNTHROID), lubiprostone (AMITIZA) for stomach. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the flu shot (influenza vaccine) in the past for immunization and got sick once afterward, she was not sure if it was food poisoning or the flu vaccine, she didn't get one this year. Patient's husband reported that patient got the vaccine yesterday (27Dec2020). She felt fine all day but started feeling bad when she went to bed on 27Dec2020. She was experiencing aches, pains hot flashes and a little fever a little over 100. She had a miserable night. She had body aches and pains, hot flashes and a little fever started around one in the morning of 28Dec2020. The fever was a little over one hundred. It looked like she what she got was normal side effects. The reporter didn't know how long approximately and how high her fever could get before he called the doctor. She had started to feel better on 28Dec2020. Then she was down again. She didn't feel great when she went to bed and then was up from 1AM to 2AM until now (28Dec2020). From 1AM or 2AM until 7AM or 8AM of 28Dec2020 it was the worse with bad aches and pains. She couldn't get comfortable. Alternating between fever and chills. Around 8AM to 9AM it started to get less and the aches started to get less. She didn't have a fever and he had checked 4 or 5 times. Around 2:00PM on 28Dec2020 she had the fever of a little over 100. The hot flashes were moderate to severe. The cold was worse and she was freezing in the middle of the night on 28Dec2020. He gave her heating pads and blankets and she was still freezing. Reporter thought the second shot would be worse with reactions. She was concerned about getting the second shot. No event required a visit to Emergency Room or Physician Office. No Investigation Assessment provided. The outcome of the events was unknown. This report was reported as non-serious.

I went to the emergency room which after the Pfizer injection I had numbness sensation to my face and upper lips, nose and mouth. I feel a pulling sensation to her lips and nose. I have brain fog. I feel the injection affected a nerve in my face. She went to see her primary doctor put her on anti-histamine medication. She states she has no itching at the moment.

worry; frustration; regrets/wishing she would have never taken it; phlegm; can't talk; taking her voice, she felt like she was losing her voice; scary/"scaring" her; coughing/cough; difficult for her to catch her breath/lost her breath, couldn't catch her breath/couldn't breath; allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date 30Apr2021) intramuscular on 29Dec2020 09:16 at 0.3 mL, single for Covid-19 immunization in a hospital. Medical history included diabetic, allergy reactions, blood pressure (abnormal), cholesterol (abnormal); all ongoing, and reaction to dust. Concomitant medications included ongoing amlodipine;hydrochlorothiazide;valsartan for blood pressure, ongoing potassium for unspecified indication, BP pills (unspecified) and has cholesterol medications. The patient informed that yesterday (29Dec2020), she got the COVID vaccine shot at work, received it at 9:16 am and was monitored for 30 minutes post administration. The patient went to work and was holding the babies. The patient worked in transport in the NICU at a hospital. Few hours after the injection, while working in the NICU, she experienced coughing to the point where it was difficult for her to catch her breath. The patient started coughing so bad, she had no control. She mentioned trying to drink water and continued coughing more. The patient lost her breath, couldn't catch her breath, she had to call for the charge nurse (manager), as she couldn't breath and they took her to the ER and consulted at the ER of her facility. The patient informed that she kept coughing and couldn't catch her breath. They made her drink water. The patient has allergies, so she always has an epi pen with her. The patient felt like she had an allergic reaction to the vaccine. The doctor there explained that her symptoms were not related the Covid-19 vaccine she received earlier. The patient specified that the last time she had a similar reaction was at work and was due to dust. The patient explained that she was perfectly fine before receiving the vaccine, laughing, and so what can her symptoms be related to, if it was not the vaccine. The patient was coughing all night, can't get rid of the cough. She has called her doctor. The nurse said just to watch herself for now. The patient informed that she was supposed to go back to work tomorrow and she was afraid to go around the babies. The patient informed that today (30Dec2020), she gargled apple cider vinegar and salt water, and phlegm came out. The patient continued saying that she has still been coughing, can't talk and that it was scary. The patient informed that she was taking her voice, she felt like she was losing her voice. It was "scaring" her. She was unsure if it was the Pfizer vaccine. The patient attempted to reach her HCP and that she cannot be seeing at her clinic due to her cough. The patient mentioned that she won't have access to a respiratory clinic until Tuesday. The patient expressed her concerned about returning to work with babies and asked if she should return to work tomorrow. The patient pursued verbalizing her worry and frustration. The patient asked if she can decide not to get the second dose. The patient voiced her regrets on receiving the first dose of the COVID-19 vaccine. She stated wishing she would have never taken it and that all who have an EpiPen should not receive it. The outcome of the event cough was not recovered, Dyspnoea, Allergy to vaccine, Productive cough, Speech disorder, Aphonia, Nervousness, Anxiety, Frustration tolerance, Depressed mood was unknown.

left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the same today - did register for V-safe

Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction lasted 3 days, employee did not report to work on day 3 after vaccine.

Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Mental impairment cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left deltoid muscle felt completely numb; palms slightly flushed, felt as if heart rate slightly elevated, but not tachycardia. No rash, no hives, no difficulty breathing. Acute episode lasted about 20-30 minutes, then just felt a little off for 1.5 hours more, then back to normal. For next 34-48 hours-mild fatigue.

Euphoria began ~2hours after vaccine lasting ~2.5 hours. Unable to process information, irritability, anxiousness, generalized not feeling well around 5pm day of; went to bed. Woke up at 10:30pm with headache, took Tylenol. Wednesday didn't feel well in general, left work at noon, went home to bed. Thursday felt better but not baseline self. Friday generalized not feeling well. Saturday went to ER due to feeling much worse generally, SOB. Tests Urine, blood. Everything within normal limits.

After patient had received vaccine, a vaccinator was called by a member of the healthcare facility to assess the patient. The patient was jittery and exhibited signs of confusion approximately 20 minutes (3PM) after her vaccination. The vaccinator asked if she was diabetic and the patient replied "yes" and takes metformin. Further questioning revealed that the patient had not eaten since 9AM - it was then around 3PM. The ambulance was called and the patient went to the hospital. Probe revealed that she had not taken her diabetic medication and that the patient had not eaten or drink. Patient was encouraged by vaccinator to eat on time and take her medicine as prescribed.

Red cheeks hot face dizzy shortly after. Had to pull over and needed my son to come get me. Two hours later cheeks still red not as red. Am home. Don?t feel normal. Very dry mouth and throat.

Pfizer-BioNTech COVID-19 Vaccine EUA Chills and low grade fever (highest it got was 99.7)- started at 11:00 p.m. on 11/12/21. Not able to sleep in the night, headache started sometime in the night. Fever and chills were gone by morning. Headache resolved about 5:00 p.m. on 1/13/21.

Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and moderate to severe abdominal cramping with moderate chills lasting 6 hours. Any fluids taken ran right through me. 4 lb weight loss and muscle cramping from dehydration. 12 hours after symptoms started I was able to take fluids and eat crackers. 24 hours after start felt shaky with mild abdominal soreness but improvement progressed and by 28 hours after start if symptoms felt normal other than I felt like I did 100 sit ups!

Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at injection site radiating up and down arm and up into neck ; Body aches especially lower back developed within 24 hours with a severe throbbing type headache and ringing in the ears. Elevation of temperature by 1-2 degrees normal for me runs 97 degrees F and was up to 99 degrees F. Headache intensified with movement(ex. .bending over ,etc) Treated arm soreness and lower back with heat compresses... elevated temp and headache with rest and a lot of water. It is now over 48 hours since vaccination and all symptoms are subsiding but still present with temperature normal for me and no arm soreness. Scheduled day off from work day after vaccination but also a second day due to the severe headache mostly.

Patient seen on 1/8, 1/9 and 1/11 in ER at Hospital for Chest pain. Work up negative for acute coronary syndrome. This started hours after 2nd dose of COVID 19 vaccine. Pleuritic type pain. She was sent with aspirin and monitored. On her 3rd ER visit was given medication for anxiety and to aid in sleep (ativan). Symptoms continued and she was off work the week of 1/11 because of this. Seen in Clinic on 1/18 and symptoms had stopped on 1/17.

2nd and 3rd branches of trigeminal nerve, bilateral, more left than right: odd feeling throughout muscles, tongue felt thick, mild tongue coordination alteration. Left 2nd and 3rd branch trigeminal nerve mild numb sensation though unclear if I have mild paresis too. Mildly reduced tongue coordination continues.

Cough; Headache; Dizzy; Nauseous; Low grade fever; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231 and expiration date 30Apr2021), via an unspecified route of administration on 07Jan2021 second dose at single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included lisinopril for blood pressure. The patient stated that she took her second dose on 07Jan2021 afternoon and today 08Jan2021 the patient feel really cough "ing" (not clarified), light headache, dizzy. I am having fever "99.4" (not clarified). The patient asked are not they not safe to take Tylenol, is it okay to take Motrin or just have to be Tylenol (treatment)." It was clarified that patient experienced Dizziness, headache, fever, a low grade fever and little Nauseous. Just my whole body aches completely aches my whole body like I have the flu." The patient was treated with Tylenol for the events. The outcome of the events was unknown.

Pfizer-biotech COVID-19 Vaccine EAU Expected extreme sleepiness, could only stay awake for 20 minutes at a time for next 24 hours. O2 saturation went down as low as 91 but mostly was at 93, heart rate 112 on Jan 13, along with a 100.1 oral temp. I did not Check on Jan 12. Morning of Jan 14: 99 oral temp and 95 O2 saturation. By evening temp and O2 were back to normal: 98° and 98%. Jan 17 I experienced some wheezing. I did have COVID with pneumonia Sept 2020.

Doesn't feel like eating; Fever; Chills/ Chilled; Nausea; Severe Headache/Dull headache/Frontal headache; Fatigue; Body aches; This is a spontaneous report from a contactable Nurse (patient). This 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1686), via intramuscular, on 06Jan2021 (at 14:30) at single dose at left deltoid for COVID-19 immunisation, administered at hospital. Age at vaccination is 61-year-old. Historical vaccine included Diphtheria and Tetanus vaccine (intramuscular, at single dose) on 15Dec2020 for immunization; and Shingles vaccine (intramuscular, at single dose) on 15Dec2020 for varicella immunization. Relevant medical history included usual tenderness. No relevant concomitant medications were provided. On 07Jan2021, she woke up at 2:00 in the morning, she had a high temperature, she was chilled, she had a severe headache, nausea, fatigue, and body aches. She got up and took ibuprofen (ADVIL). She was basically in bed, she had to cancel all her appointments in the morning, she just laid in bed and the following afternoon her fever broke at about 4:30 in the afternoon then she just had a low grade temperature and a dull headache, nausea through the next day, Friday the 08Jan2021. She still has a very dull headache and just not right, kind of like a flu bug. She had no fever; she had not had any fever after Friday afternoon or Saturday. Fever started at 2 in the morning 07Jan2021 and she experienced the chills until after fever broke. Fever went above 102 degrees. She still had a little of the nausea, she just didn't feel like eating. She still had the dull headache. The nausea and headache have improved when compared to how it was on the 07Jan2021. She was back to work now she just has a dull frontal headache. The reporting nurse assessed all the events, except of 'Doesn't feel like eating', serious for disability. She stated she may have had usual tenderness but nothing like this. The patient had recovered from the event fever on 08Jan2021 and from the event 'chills/chilled' on 07Jan2021; the patient was recovering from 'nausea' and 'severe Headache/Dull headache/Frontal headache', while the outcome of the remaining events was unknown.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded due to temporal relationship. It is worth noting that patient had other vaccines not far ago, including Diphtheria and Tetanus vaccine and Shingles vaccine on 15Dec2020 for immunization. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a warm sensation after the vaccine in my deltoid muscle then felt it go up both my ears, around my head. I then felt the same warm sensation in my abdomen, followed by buzzing of my entire body with light headedness. I could breath, I could talk, but I had an urgency for others around me to know that I wasn?t feeling well and something was not right. I asked my colleagues if someone could take me to the ER for monitoring. They immediately put me in a recliner and elevated my legs. This did not relieve my symptoms and asked to go to the ER. I got to the ER and laid on the stretcher with continued increased buzzing sensation especially in my finger tips and arms. My vital signs were 148/88 and HR 88 (elevated from my normal of 100-120/60-70, HR 60s). The buzzing turned into a sensation in my arms that rumbled erratically. I thought something bad was about to happen and that my blood cells would burst. Then I also felt icy cold in my arms and my gut. Next what happened were teeth chattering shivers. All these symptoms occurred in a matter of minutes. They started an IV, drew blood, gave me Benadryl and ran IV fluids. My vitals did not reflect what I felt inside, but as symptoms let up, my VS returned to normal. As quickly as the symptoms started, they eventually calmed down and I was able to leave the ER in 1.5 hours to go home. I was very scared. The ER doctor thought I had a hyperimmune response to the vaccine.

Joint pain (all joints felt like they were on fire - different than usual arthritis pain - could barely walk or hold a cup of water due to pain), significant fatigue (barely able to get out of bed) recurrence, brain fog recurrence, headache , muscle pain, I felt almost like I did when I had COVID - starting to subside now 4 days after vaccination

felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right deltoid on 27Dec2020 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN); all taken for hormonal treatment from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: some extreme fatigue (non-serious) on 27Dec2020 with outcome of unknown, nausea (non-serious) on 31Dec2020 with outcome of unknown, dizziness/lightheaded (non-serious) on 31Dec2020 with outcome of unknown, vertigo (non-serious) on 31Dec2020 with outcome of unknown, felt very uncomfortable (non-serious) on an unspecified date with outcome of unknown, mental fogginess (non-serious) on an unspecified date with outcome of not recovered. The patient stated she wanted to report her experience with the first dose of the Pfizer Vaccine (COVID Vaccine), which was received on 27Dec2020. The patient stated she experienced some extreme fatigue starting that first day and then about four days later on 31Dec (not clarified), she experienced some nausea, some dizziness that advanced to vertigo and that occurred late at night; at the time she was getting ready for bed time around 22:00, but it just lasted for about one hour. The patient "went to bed just thinking about and staying in bed and then I felt very uncomfortable and I got up and then I went back to bed about at 01:30, that's how I just fell asleep." Then the next day, the patient was not feeling the vertigo, however, she was feeling lightheaded for about two days and then the fatigue continued to 08Jan (not clarified). Then starting on a Saturday, the patient "felt normal myself energetic and positive." The patient was still feeling mental fogginess, " I was getting here." The patient stated that dizziness and vertigo, or the mental fogginess were not listed on her list of possible side effects. The patient even asked her doctor what it would be, and the patient let her know that she received the vaccines. The events did not require any emergency room or physician office visits. The causality assessment from the reporting patient was reported as: "Yes, I believe it did."

The first thing I had nausea and stomach pain (for 2 days) in the AM and then it went to achy, joint hurting and headache. It was not like I could not work or anything, it was just there. On the 9th day I woke up with fever and chills and a super bad headache and I felt so bad I could not even go seek medical care, I finally went after 3 or 4 days feeling like that. At the walk in clinic they tested me for flu, covid and strep and on the rapid the result was negative but when done the PCR it came back positive (around 12/29/20). I did not have any respiratory issues on this one. I do remember having diarrhea.

I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs feeling weak and wobbly. Could not perform my work duties. Progressed to Rigors. Lasted at least 3 hrs in it's severest form. Now, 24 hrs later I still have some hand tremors, and legs are weak. Shoulder, knees, hips achy. I'm very fatigued. Right arm soreness @ injection site. All events were reported. I was sent home from work, had to be driven home. I rested, slept and hydrated the remainder of the day. Did not go to work today.

STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine. Went home early from work. As of 1/22/21 0830, still has chest pain but not as intense and it radiates to left shoulder and towards back (advised employee to have this evaluated)

Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfort, disoriented, feeling a sense of impending doom.

Left fingers tingling 10 minutes post vaccine. Next day felt it spread to whole left side and left eye felt "weird." Took Advil, got better after no difference with Tylenol. Then stopped the Advil and symptoms persisted. Then had tingling of head and neck. Saw her physician and Carotid flow study was normal. Waiting for MRI approval. Has been working with the symptoms.

After first dose I felt an overall odd feeling . no shortness of breath etc, just odd. I was thinking it may have been just some anxiety. I left the center after 15 minutes and came back to Pediatric office where I work. I did take a Zyrtec and felt completely better after approx. an hour. After the 2nd dose I did mention I had felt odd after 1st dose and decided to sit for 30 min. I felt about the same as I did after the 1st dose so I left. when I got to my car my face was flushed. I was not tachycardia just a very odd felling in my head and then my tongue did start to itch (or feel funny) . I took a Zyrtec and went home. I never had any swelling of lips or tongue, no trouble breathing. Pulse stayed constant around 80. This time the symptoms lasted approx. 4 hours. I I did continue to take Zyrtec for 3 days after injection.

Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, slight left arm ache, loss of appetite, insomnia, body/joint aches. I took a couple of Aleve tabs 24 hours after the vaccine and then switched to 500 mg Tylenol 30 hours after the vaccine, with no relief of symptoms from either meds. I've been sleeping (taking 2 hour naps) and called off of work (I work in home health). Today, 1.27.21 I feel better, still having 'hot flashes' and some chills (again, without fever). I feel tired, slept last night for 12 hours (no further insomnia). I am eating, but really have no appetite.

unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Increased HR, Weakness, Throat Irritation, Diaphoresis. Patient was asked to sit in observation for 30 min. Hx of allergies. Very anxious, anxiety causing increased HR and Sweating. throat itching/tightness. Legs elevated, 50 mg of Benadryl given.

alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.

12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, felt very cold and had difficulty getting warm, headache, all body achy, unable to get into any comfortable position and very limited sleep. By 24 hr after vaccine and continuing until 40 hr after, nausea most of day, severe muscle pains, headache, difficulty moving from pain and general weakness, head swimming sensation. felt like skin crawling sensation all over. By 48 hrs, much less headache and nausea, able to eat, still had skin crawling sensation and achy but able to walk around a bit, not able to go outside. By 58 hr after (at time of report), just weak all over feeling, head fuzzy but better. Treatment: ondansetron x 2 doses (at 24 hr and 20 hr), Nurtec x 2 doses at 15 hr and 20 hr), Acetaminophen 8 hr x 2 doses (at 36 hr and 48 hrs)

(This is a duplicate entry. I mistakenly entered that patient received the Moderna vaccine, but she in fact received the Pfizer.) I got the 2nd dose of the Pfizer vaccine late last Wednesday afternoon (1/20). Before the 2nd dose, I premedicated (as instructed by my medical office) with Benadryl 50mg and Pepcid 20mg (for the histamine blocking effect) since I had terrible itching for about 36 hrs after the 1st dose; but the itching didn't begin-after the 1st dose-until about 8hrs after the shot & became intense 2 more hrs later. I had itching the night of the 2nd dose that kept me awake part of the night but was FAR less intense than after the 1st dose. I came to work Thurs not feeling ill--just cold and tired all day (I attributed to the cold weather and not sleeping well). Thurs about noon I began feeling ill--like I was coming down with the flu; I went home after my shift and found my temp to be 100.4. Shortly thereafter it was 100.9. I thought it would pass by morning so I just showered, drank fluids, took Tylenol and slept. By 0200ish Fri 1/22 I still had a fever of 100.9 (even with Tylenol on board), a bad headache, sinus congestion, and significant neck and back pain so I called out for work. I continued to treat the fever and by noon Fri the fever finally had resolved-along with the head, neck and back pain. I've been fine since.

Severe sudden diarrhea, headache, weakness, taste of smoke with burning sensation. Today unable to do anything, very tired.

feeling tired but also edgy; edgy/ nervous; anxious; unable to focus; headaches; blood pressure was much higher than normal; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284) via an unspecified route of administration on the left arm on 11Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and back pain. Concomitant medication included levothyroxine sodium (SYNTHROID), ibuprofen and ergocalciferol (VIT D). The patient previously received 1st dose of BNT162B2 on 20Dec2020 for COVID-19 immunization (left arm, lot number: EH9899). After receiving second dose on 11Jan2021 the patient was feeling tired but also edgy, nervous, anxious, unable to focus, some headaches. Discovered 18Jan2021 that blood pressure was much higher than normal and associated with the way I was feeling. Had to go to primary care to have medication prescribed. The events resulted to a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. Patient was not pregnant. No known allergies. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19 (Nasal swab), on 13Jan2021 and 16Jan2021 both test results were negative. Outcome of the events was not recovered.

I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty bad symptoms on first dose by all info i have found. The actual shot was given by another facility than listed previously. I recieved the first dose of Pfizer at Health Dept . No other location information was provided by them. When i got the shot, a blood vein and possibly a nerve was hit. The nurse did everything properly i think to correct and notify other RN. It caused immediate pain in left fingers and arm felt heavy. That continued for days, but not too bad and injection site itself really was not very sore. My concern was how sick I felt starting within 6 hours of the injection and how long it lasted. I had pretty much instant nausea- no vomiting- mild but persistant, severe fatigue and general overall uneasy/sick feeling. Joint pain started within the 6 hours, along with a few odd pains in neck and right abdomen. Was extremely chilled for hours, pretty bad tension /tight feeling headache, jittery feeling and foggy. I took a 500mg Tylenol about 8 hours after the shot, and it helped to relieve most symptoms to a degree that was nagging, but tolerable. I pretty much went through this for about the next 3 days and off/on to the 5th day

facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no itching. Didn't notice until I left the vaccine site and was on the way home in car because covered by mask. Note I am a very fair skin, freckled red haired woman. I was very, very nervous and had gotten myself to the point of tears. Perhaps the flushing was from that. Have had similar flushing when drinking red wine. Swelling in lymph node in supraclavicular area on same side as shot. Has happened with Flu shot once. Slight fever for a short period of time and fatigue. I continue to have slight shortness of breath from having covid on. 4/3/20. Nothing different.

Patient described having a "mild reaction" to first dose Pfizer BioNTech vaccine, and pre-mediated with 50 mg diphenhydramine as well as her morning cetirizine 10 mg before the second dose. Approximately 10 minutes s/p second dose the patient experienced dizziness, facial tingling, anxiety, hard and soft palate numbness, and flushing. She was helped to a stretcher and her BP was 204/94. The patient was taken to the ED for further monitoring. In the ED, she denied any throat swelling, tongue swelling, or difficulty breathing on arrival. She also denied any chest pain and palpitations. She received methylprednisolone 125 mg IV x 1 and a liter of normal saline, underwent observation, then discharged home uneventfully.

30 minutes after injection: severe headache, general feeling of illness. Following day in the morning, headache, left arm in extreme pain, facial numbness, disorientation, inability to talk, confusion, difficulty breathing

Headache; cramps; Woke up feeling terrible; Over all body ache; Like no energy; This is a spontaneous report from contactable Pharmacist (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)Lot number EL1284, expiration date 30Apr2021, Intramuscular on 13Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient previously received first dose of BNT162B2 on unknown date. The patient received her second dose of the Pfizer vaccine a week ago on Wednesday, '2 days ago' (not clarified), so it's 9 days ago and she was wondering if she could still have, she felt fine for over a week and then yesterday (22Jan2021) she woke up feeling terrible, just over all body ache, 'cramps' (voice feeble not clarified further) like no energy and she was wondering that. She was getting a headache now from this conversation. She did take Acetaminophen yesterday and she was ready to take it now, that's a bad headache. The outcome of all events was unknown.

pt stated about 10 minutes after rcvg vax she started feeling funny, warm and her heart was racing. She was checked out by the attending nurse at the vaccine facility. Her pulse was 120 and BP was 189/89. Pt drank a bottle of water while her pulse came down. About 5 minutes later her heart was racing again and BP back up. She was monitored for additional 15 minutes. During this time she had another episode with the same symptoms so she was rushed to the ER. Her heart rate was 110 and blood pressure still 189/? She was monitored for about an hour and 20 minutes. Pt was released from ER about and 1 1/2 ago and has not had another episode so far. She was told to FU w/ PCP in 2-3 days.

AT 3:41PM PATIENT TONGUE FEELS "OFF", HAS HAD FEELING FOR 10 MINUTES BEFORE REPORTING. PATIENT REPORTS FEELING SMALL AMOUNT OF DRAINAGE IN THROAT. ADMINISTERED 50MG OF DYPHENHYDRAMINE, IM, RO AT 3:43PM. PATIENT MONITERED VITALS EVERY 5 MINUTES. AFTER MEDICATION PATIENT REPORTS FEELING DIZZY AND "LOOPY" AT 5:17PM PATIENT COMPLAINS OF TONGUE SWELLING AND BLOOD PRESSURE ELEVATED. EMS CALLED, ARRIVED AT 5:34PM, PT TRANSPORTED TO NORTHSIDE HOSPITAL. FOLLOW UP CALL, NEXT DAY PATIENT STATES SHE WAS GIVEN STEROIDS IN THE ER AND PRESCRIBED AN EPI PEN FOR FUTURE USE.

I am a teacher, so thankful to have received my vaccines. 40 years ago, as a young teacher I had a bad reaction to a flu shot and I have never had another one. I didn't think this vaccine would be similar. I am not someone who gets very sick often and I don't miss days of teaching for illness. Note that my first vaccine on 1/21 had no effects. I did not even get a sore arm. I even sort of bragged about it. The 2nd vaccine on 2/11 seemed fine until I woke up the following morning feeling like I had been hit by a truck. I yawned for 3 hours straight, but still made it to school and worked and taught 6 online classes. I took an ibuprofen that morning because I was feeling so odd. By 3:00 I was driving home (40 minute drive) and I cried uncontrollably the whole way home while my hands and feet were shaking. Not normal for me. When home I went almost immediately to bed. I had a slight temperature and was dizzy. I thought I had the chills but it didn't feel like any chills I have had before. Usually my teeth would chatter and I would feel hot and cold at the same time. The hottest temperature I had was 100.5. But by 9 I started shaking so profusely that I couldn't pick up the thermometer any more, I couldn't use my phone, or take a sip of water. I stumbled to the bathroom holding onto things all the way. My husband was not home, or I imagine he would have called 911 at that point. I kept shaking a lot through the night and kept praying that it wouldn't happen to my heart. I fell asleep eventually and dreamed of fish flopping inside me and my neighbors coming over to to see why the bed was knocking against the wall. Saturday morning I woke up and all the shaking had stopped, but I found I was too weak to get up much. Today is Monday and I mostly feel normal, except a little dizzy when I move and the top of my head is tender to the touch.

After patient received first dose of Covid vaccine patient experienced a reaction as described "feel fuzzy" and lack of self awareness five minutes after dose. That evening patient contacted her primary care provider and has not spoken until then. Patient still complains of not feeling herself and currently has not received her second dose and is worried of lack of self awareness.

Around 2am on 1/8/2021 I woke up having chills, nauseas, fever, dizzy felt like I was going to faint, foggy head, very fatigue, shaky weak legs & body aches. The chills, body aches, fevers & dizziness were under 48hrs. The other symptoms lasted till 2 days before I got my second dose. Tight Chest going on but I think it might of been anxiety. Phone consult with doctor and prescribe some steroids.

Around 1 am on 1/29/2021, hot flashes, fever 99, & a little bit nauseas this lasted 48hrs. My legs felt weak & shaky legs and fuzzy head. I feel with no energy. This symptoms are still going on.

I don't want to file two reports. I had an episode of feeling very dizzy and when I laid down for an hour and I got up I couldn't remember names of anyone, went to hospital to rule out stroke. EEG and double echo both normal. MRA and MRI, no evidence of stroke, transient global amnesia, it took a couple hours for me to get back to normal. I also had a shingles outbreak 10 days post both vaccines.

Pain at the injection site was typical for vaccination and was essentially gone by the next day. Headache started within one hour after vaccination and was severe 4 hours after vaccination. Next day morning I woke up with all my face swollen, runny nose, headache, stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year and dizziness. Face edema and runny nose subsided 3 days after injection. Stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year persists 7 days after injection. Dizziness and foggy head became worth 7 days after injection.

rash on neck; felt a little off, it could have been in her head or maybe was paranoid, but wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL; developed a bad rash, hives, all over her body; developed a bad rash, hives, all over her body; itching; a few bumps kept increasing up to 3 days later; her feet were incredibly hot over the next 3 days; arm soreness; She was unable to sleep from being so itchy; Allergic reaction; This is a spontaneous report from a contactable consumer herself. A 61-year-old female patient received bnt162b2 (, Solution for injection, Batch/lot no: EN5318), via an unspecified route of administration on 04Feb2021 15:00 in the left arm at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously did get a flu shot in Nov or Dec2020. The patient developed a bad rash, hives, all over her body and itching on 10Feb2021. She reports, her feet were incredibly hot over the next 3 days on 07Feb2021. What started off as a few bumps kept increasing up to 3 days later. She was unable to sleep from being so itchy. Her doctor said it was an allergic reaction and prescribed an antihistamine after which it left in Feb2021. She was due for the 2nd dose of the vaccine on 25Feb2021. The patient did not had any investigation assessment. The patient states that there was little information out there to compare the experience she had. Wanted to call to make Pfizer aware of that and maybe get some more information out there. Has printed out the fact sheet and assumes she should not get the second vaccine because of what happened the first time. Wants to clarify what happened and share with Pfizer this information since she can't find much information for people who have had a delayed reaction. Went to get the vaccine on 04Feb and doesn't consider herself an allergic type person. Has no allergy to foods, medicines, only gets poison ivy and bug bites like most people. By Monday, the 4th day (08Feb2021) after getting the vaccine, noticed a couple of bumps on the wrist and does not know where else and didn't think of it as anything else. Thought it was a bite or she touched a plant and then it went away. It was not much. In the evening of Tuesday she had a bad reaction and on the 10th (10Feb2021) she had rash, hives, and itching that just moved to different places over the body. Her feet were so hot on the 3rd day and had to plunged them into cold water and used Epsom salt off and on and it helped some. This happened only for 2 nights and the reason she didn't go to the doctor, it went away. Again, mentions the first night she had a couple bumps and didn't think much about it. The second night, it was all over her body, the rash, and she took Epsom baths that helped, but she didn't get much more than an hour of sleep. She tried to take pictures of her thighs and backside, but unable to take good pictures, not a selfie person. The next morning she had her husband take pictures in case it went away and she went to the doctor they would have pictures to show. Her husband thought it may be shingles. Called the doctor on Thursday and had pictures to show her since the rash went away. Again, mentions the reaction was so bad on Wednesday. The doctor didn't believe areas on pictures of her back were shingles since shingles does not come and go away like that and that she must have had an allergic reaction to something. Provider didn't believe it was from the vaccine. Was given a prescription for Hydroxyzine HCL 25mg and was informed if areas didn't improve or returned she may need to see an allergist or immunologist. After the appointment she didn't get much sleep and woke up at 4pm in the afternoon and felt a little off, it could have been in her head or maybe she was paranoid, but she wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL and went to bed at 7:30pm and didn't do anything since. Got up and the reaction/rash, hives, itching was all gone after taking only one. It's like an antihistamine or Zyrtec. No further details provided. Later mentions after getting the first vaccine on the 4th, the next day she had arm soreness up until that Monday when the rash started. No further details provided. Says as far as recommendations were concerned for the paper she printed, the fact sheet. It says pretty much listed, she shouldn't have the second dose if difficulty breathing, swelling in the face and throat. The only thing she had was the rash on the neck, not the face. Paperwork also lists heart beating fast, or severe allergic reaction. The patient had no emergency room visit. The patient visited the physician office. The outcome of the event hot feeling in feet was recovered on feb2021 and rest of the events was recovering.

Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly resolved some memory issues and headache still 2 days later

still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 went to get covid test but due to blood in my nose received antibody test which was neg; bad headache; winded; vomited; diaherra; coughing/cough; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiry date not reported), via an unspecified route of administration on the left arm on 20Jan2021 18:45 at single dose for COVID-19 immunization. Medical history included diabetes mellitus and high BP from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, losartan potassium and sodium fluoride (CREST CAVITY PROTECTION). The patient previously took septra and experienced allergies. The patient reported that on 21Jan2021, they woke up and brushed their teeth then at 6:40am blood with large clots gushed from their right (rt) nostril. The patient went to ER and stopped bleeding after 2 hrs. On 22Jan2021, the patient woke up with bad headache, winded, vomited, diaherra (as reported), coughing. On 23Jan2021, they went to get covid test but due to blood in their nose, they received antibody test which was negative. On 24Jan2021, the patient was still feeling bad with all the above symptoms. Then on 25Jan2021, they went to ENT doctor who cauterized their nose and stated that since antibody was negative to take the maderna vaccine since they have no antibody in their system, the Pfizer vaccine did not work. From 26Jan2021 to 13Feb2021, the patient felt same started feeling better 14Feb2021 but still have sore muscles in their shoulders and cough. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 23Jan2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of epistaxis and clot blood which include the doctor cauterized their nose. The patient recovered with sequel from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the epistaxis and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including CBC and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

On day 2, I developed confusion and could not focus making it impossible for me to complete my work at my job. The confusion made driving dangerous. By Friday, I went to my PCP and they noticed that my blood pressure was only 90/58 and they were concerned so she told me that she was calling my cardiologist who said to reduce the dose of my Diltiazem from 180 mg daily to 120 mg daily. She also said to take a few days off of taking the Diltiazem. I have also had a serious increase in Tachycardia. That evening I went to the ED because I was so weak and couldn't breath well. I am also retaining a lot of fluid. The lab work indicated an elevated Pro-B-Natriuretic Peptide level of 227. I am still not well and each doctor I have spoken to said they believe it is due to the vaccine. I do not know if I should take the second dose.

With in an hr. my left thigh muscle hurt and my left knee was starting to stiffen up. In 2 hrs., varicose vein in left thigh was extremely throbbing, I could barely walk on stiff knee. I had a trouble night of pain on Sunday 2-28, Monday , I could barely walk on left leg & still had thigh pain, I almost fell down stairs 2x from leg buckling, I did fall down in the kitchen and the fam. room from knee buckling, not supporting my body. I used heat, ice, rest, ibupfen, advil, tynelol, ben-gay, icyhot, CBD cream. I used it all. Today is one week and the thigh pain is gone but knee is still stiff. It no longer buckles, but I still can not fully walk. I am using a cane. I have been working from home all week, but can not cook for myself. I have to sit in a chair in the shower. I did contact my Dr., who said keep doing everything I am doing, that as long as it getting better every day. I am afraid to take 2nd dose.

Patient received first Pfizer COVID vaccine and in observation area started complaining of scratchy throat. Exam was normal. Calm patient, clear lungs, strong pulse. No rash. Gave positive answers to all questions, such as do you itch 'a little,' do you have trouble breathing 'a little.' I suspect anxiety. Given Benadryl and continued monitoring. All symptoms resolved. Observed total of 45 minutes and discharged home. Ok for next vaccine.

I had hallucinations. I thought it was vivid dreams but I could not wake myself. I even went to bathroom three times during the night and could not stop them while getting up and walking to bathroom. I would sit up in bed and even get out of bed but they would not stop. I?ve never had this happen ever in my life. I was crying out and sweating. I have also had severe fatigue, even much more than what I experience with CFS.

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium

Monday 3/08/21 after work, I was very tired and achy. I went to bed and slept 10 hours. When I eat I had diarrhea. On Tuesday, no appetite. Ate very little - crackers, and some chicken noodle soup. I had headache and chills on Tuesday evening, Wednesday and Thursday. I didn't feel well at all. Lightheaded Thursday morning, another diarrhea after a small breakfast. Called my doctor, suggested a covid test. Had a rapid covid test. It was negative. Teleconference call with my doctor on Thursday at 3pm. Nose bleed Friday morning 11:00am.

Everyday since vaccination fever of 99.5 (no higher ), chills, headache, extreme tiredness (sleeping 15-18 hours per day)

Constriction of throat followed by heaviness in chest, followed by a headache. Had distress but was afraid to say something. hands tingling fingers both hands. NOT hyperventilating. Oriented but sluggish to respond to questions. initially elevated bp then hypotensive. after leaving vaccine clinic throat felt like a golf ball and went to ER to seek treatment. DX- allergic reaction and given IV Benadryl, Pepcid and solumedrol.

3-10-21 7:15PM PT 'FEELING ANXIOUS, NUMB, DIZZY - IS DIETING AND IS TAKING ADIPEX. ONLY ATE TOAST TODAY AND 2 BITES OF CANDIES'. GIVEN JUICE AND CRACKERS. 7:25PM 'FEELS BETTER'. AMBULATORY TO EXIT WITHOUT DISTRESS. 3-11-21 9:30AM PT STATES 'FEELS 100% BETTER NOW'.

Bi-lateral breast pain. I have not had much breast pain with my fibrocystic disease as I have gotten older but for 6 weeks after the second dose it felt as bad as it ever has. It kept me up at night and I had to take OTC pain relievers.

Within 10 min I started feeling dizzy, kind of loopy. I didn't think anything of it. I Waited 15 min, got in my car, and felt the need to defecate. Went back in the store, completed, got in my car to drive home. Started to feel even dizzier but kept driving. Felt like maybe I was having a little bit of a strain swallowing but was breathing fine. I took 2 puffs of my Albuterol. Still felt unnatural and anxious. Got home and started to feel a little better within 15 minutes. The arm is sore, not too much of a bother, body aches. Chills for a few hours. Got up and went about my day. Tired and anxious.

acute subdural hemorrhage (presented as word finding difficulty and confusion for 2 days per son who convinced his mother to come in to ED)

I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by 36 hours of intermittent fever combined with chills, fever was high but not measured. I was very weak and at times was unable to get out of bed or stand. I had significant joint and overall body pain, at times unable to stand up straight. As this subsided about 36 hours I remained quite weak. On the night of 16 March I was woken up at 1 am with a very severe headache. I took Tylenol and 5 hours later still had the headache - it subsided after about 8 hours. I additionally had stomach cramping but no vomiting or diarrhea, and had no bowel movements until the episode cleared up. During the 4 days that this occurred I tried to keep well hydrated but still had quite concentrated strong urine. I took Tylenol periodically throughout the 4 days, not starting until after the injection was administered. I still feel a little loss of balance/brain fog and have recurring headaches (not migranes).

Fever as high as 100.7, muscle aches, headache severe, fatigue moderate to severe, Three asthma attacks. One was severe taking 2 hours to resolve. Worse on 3/20 than today on 3/21. I?ve taken 2 Tylenol and used my rescue inhaler 4 times. The inhaler improves my breathing, but I don?t feel normal yet. Oxygen saturation between 93-96%. If still experiencing symptoms will call PCP and/or go to urgent care. If I?m still coughing I will have to reschedule a hematologist appointment.

1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, started to shiver, jaw rattling, immediately had hot tea and wrapped in blanket. 3. Nosebleed, very unusual for me, 7 am. 4. Nosebleed, severe tinnitus, nausea, had to get out of bed and get to restroom, immediate bowel movement, severe dizziness vertigo getting back to bed. Slight tinnitus day after while writing report. Still have low nausea. 5. Sore arm for 4-5 days.

Patient DOB 5/16/1959 received 1st dose of Pfizer Lot # ER8730 and was waiting in the 15 minute observation section when she stated that she felt "swelling of her face and tingling of her lips." Blood pressure was 196/98, HR 85, O2 97%, Temp 98.1. Patient was alert and oriented x 4. Patient stated that she was very anxious today and has allergies to dairy and pollen. Patient confirmed that her husband was on the way to pick her up and drive her home. EMT administered 25 mg of Benadryl PO at 12:32 pm. Patient observed for an additional 50 minutes until her husband arrived to pick her up at 1:22 p.m. Patient stated that she was feeling better and was able to walk unassisted with her husband. informed patient to go to ER or call 911 if symptoms worsen.

Sore arm at injection site with both shots. With the second shot only: Next day @ Approximately 7:00 am started feeling dizzy. Approximately noon stated feeling chills and general body aches. 6:00 pm took ibuprofen and slept until 6:00 am next day . All symptoms then gone

On 3/19/2021 around 4:00 I started with body aches, headache, fever, and chilling. I continued with that during the night and on 3/20/2021 I still had the body aches and felt weak. On 3/21/2021 I noticed that I had a rash developing in places. On 3/22/2021 I woke at 5:00 a.m. covered with a rash over my entire body that itched. I took Benadryl and that is when I went to the ER.

Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was normal and thought I might feel flying for a bit but that it would wear off so I did not report feeling anything at the clinic. I left the clinic and got in the car to drive home and felt a weird feeling in my throat reminiscent of my esophageal spasm and then it felt like someone had their hand on my throat squeezing my throat and felt like I needed to take deep breaths to expand my lungs. Within a minute or two at most, my lips, tip of my tongue, tip of my nose and face beside my lips and under my cheeks started to tingle and go numb. My insides felt swollen. I had a doctors appointment and went there after picking my son up at home. I reported my feeling to my doctor who prescribed a steroid for 3 days and told me to also take Benadryl or Claritin, which I did. However, today is day 4 after my vaccine and today is the first day my insides don?t hurt.

Around 11, 11:30 the pain woke me up because it was so bad. It was hot and there was a big lump under my left arm pit (was very tender). I did not go to sleep like that. I did not have any symptoms by the time I went to bed. I also felt hot, and then cold, then hot, then cold, I would feel too hot and then too cold, freezing, I could not keep my temperature under control. I had to call in at work during the weekend I was feeling so bad. I had a lump under my armpit the size of a fist and I could not close my arm completely. It was huge and painful. I decided to go to a clinic over the weekend (unsure if Saturday or Sunday) to seek medical care and they ran some labs and a CBC to check for infection. All results came well no infection. They suggest to keep taking Tylenol. By Monday or Tuesday I started feeling well enough to return to work. The lump was still present and took about a week to go down. The injection site also was sore for a while, about a week also like the lump.

I had swollen and very, very painful - the muscle on top of my shoulder (Trapezius) on the right side and I took Advil late at night time because it was so painful I couldn't sleep. My arm was not sore but that muscle was. That seemed to calm it down (Advil). The next morning, I was very swollen under my right armpit - I figured it was my lymph node. It was uncomfortable and very noticeable - quite swollen for three days. It took about a week to go back to normal. I also had abnormal fatigue and that took longer to resolve - that took about two weeks to be resolved.

Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tightening of chest every so often; acid reflux; hot flashes; sweating; stomach aches; upper abdominal pain radiating to back; severe fatigue; Dizzy/dizziness; stomach feels odd; Headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6198), via an unspecified route of administration, administered in upper left arm on 25Feb2021 9:00 (at the age of 61-year-old) as single dose for virus (COVID-19 immunisation). Medical history included chronic pain, pancreatitis, allergic to medications, old injury in her right arm, menopause and an ongoing mass in parotid lobe discovered in 2019 with CT scan. MRI performed in Mar2020 and CT scan in Oct2020. She stated that they are just watching it because it has not changed. Well defined borders are present, caller stated that doctor was unconcerned. Her mother had heart disease. Ongoing concomitant medications included ibuprofen for chronic pain and gabapentin from 2019 for chronic pain. The patient also took unspecified medication for pancreatitis. She has taken all kinds of stuff after pancreatitis but they do not work. The patient got deadly ill from the flu shot. Unsure of onset age, vaccine/brand name, or vaccination date. She stated that it was before 2003, possibly in the late 1990's or early 2000's. The patient had no history of all previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. On unspecified date the patient experienced diabetes; on 25Feb2021, the patient experienced dizzy, stomach feels odd, hot flashes, severe fatigue, sweating, stomach aches, acid reflux, upper abdominal pain radiating to back; on 26Feb2021 she experienced tightening of chest every so often; and in Feb2021, she had headache. It was further reported as follows: The patient stated that she took the Pfizer shot, clarified that she received the Covid-19 vaccine, on 25Feb2021, not quite 2 weeks ago. She stated that she had a little bit of a reaction after receiving the vaccination while there, so they were monitoring her. She has been experiencing hot flashes, sweating, and stomach aches for 2 days. She cannot get rid of hot flashes and that she has not had a hot flash in 2 years. She states that she has been down for 2 days with fatigue, that it's really bad. She is inquiring if the side effects that she is experiencing are common side effects and if it is ok to get 2nd shot. Her second vaccine is scheduled for 17Mar2021. She stated that she wanted to take the time to make a report as she is allergic to medications. While inquiring about dates of vaccines and side effects, she stated that she was experiencing tightening of chest every so often. She stated that she only had a few days of stomach pain and she has not stopped eating. She is unable to concentrate (unspecified date) and she has been experiencing headaches, experiencing them twice in 2 weeks. She also reported that she has been having upper abdominal pain radiating to her back. This concerns her, every time she gets it, it scares her. She had pancreatitis when she was 36. It is a nightmare thought. Does this sound like maybe she is possibly starting Diabetes? She reported that this shot has triggered everything. She has an old injury in her right arm. Her arm is killing her, her hands are swelled up, she has acid reflux again, she felt terrible. She stated that the dizziness not as strong as it was at the beginning. The fatigue it comes and goes and that she has spurts where she is energetic. She stated that it's more on than off. She is no longer having stomach aches. She compared the pain to pains of constipation. She also stated that she was constipated after receiving the vaccine on unspecified date. She had nausea at the beginning. The tightening of chest happened off and on, the last day that she experienced tightening of chest was on Sunday. For acid reflux, she is taking Zegerid as treatment, 20mg 20 mg capsules by mouth once daily as needed. She started this on 02Mar2021. She experienced upper abdominal pain yesterday and some this morning, but it was mostly in her back this morning. Her Sweating is off and on. She experienced headache just a couple of times but that she has not had one in a while. She stated that they lasted only an hour or two, and that she does not usually get headaches. She suggested that these may be due to sinuses and weather change. She has been taking Ibuprofen twice a day as treatment. But she normally takes Ibuprofen for chronic pain. Supposed to be 3 times a day but she does not want to take that much. She stated that all of this could also be stress related and that this could also be menopause. The patient recovered from stomach aches on 02Mar2021. The outcome of the events dizzy, sweating, tightening of chest every so often, upper abdominal pain radiating to back, headache was recovering; the outcome of stomach feels odd, hot flashes, severe fatigue, acid reflux was not recovered. The outcome of the remaining events was unknown.

Directly after getting the shot I was sleeping harder than I ever have for about 14 days then on March 4 woke up after a very deep sleep tired the next day the same thing March 5 woke up extremely fatigued March 6 same thing woke up extremely fatigued and after going for a short bike ride started getting an intense headache, set up got very dizzy, then proceeded to throw up harder than I ever have and so debilitatingly that I had to call the paramedics and they took me to the emergency room. The ER doc at first said that this could not be an adverse effect 14 days later of the first Covid shot, but then he said he didn?t know, for the next nine days I did not leave my house I was so exhausted. I am an athlete and exercise every day have tons of energy all day long and have never felt this way before. I then met with my regular Doctor Who ordered tests of different varieties everything came back normal and to this day which is now March 25 I have extreme fatigue and I can barely work. Like I said above I am an athlete I run five days a week ride my bike two days a week and swim generally two or three days a week and work as a teacher and I can barely do any of that.

On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 102. On 3/22/21 and continue to have swelling in my left armpit (Lymph node area), spasms in my left shoulder blade and surrounding soft tissue adjacent to my left armpit and neck area. I have experienced soreness in that arm/shoulder but not at the injection site - overall bicep and clavicle area. I have been able to alleviate symptoms to a degree by taking a tylenol once or twice a day but the pain is limiting some of my daily activities to a degree.

Within 15 minutes following her COVID vaccine with concerns for a lump in her throat. She states she is able to swallow without difficulty. She denies any shortness of breath, chest pain, nausea, rash, or any other symptoms. Benadryl 25 mg given. Continued to monitor and improved

Patient expressed anxiety. Had same symptoms with flue vaccine in 10/2020. Left arm injection site no redness, warmth. Patient expressed both parents recently passed away and expressed increased anxiety. Pt walked to the car, steady and stable. Pt will take tylenol as prescribed, rest, and hydrate. Recommend pt to follow-up with PCP on Monday for anxiety and elevated BPs. Pt denied HTN. Vitals: At 13:25, 160/82. 1 minute after 99 At 13:45, 160/82, 98HR, 99% spo2.

Between 10 and 15 minutes after receiving the vaccine, I felt like someone had thumped me in the chest over my left breast. I tried to breathe deeply, and I started to feel light headed. I didn't tell anyone, I was let go after 15 minutes. I sat in my car about 5 minutes and then decided I was worse. I was weak and shaky and light headed, my top lip was fuzzy feeling. I didn't feel like there was a blockage in my airway but I felt like I was having trouble getting my rib cage to expand so I could breathe. I went back in and was sat down, I was evaluated. Paramedics were called, by time they came I was lightheaded and I was foggy brained. I couldn't respond easily. My BP was 165/99 and my heart rate was 98. my O2 was fine but by that time I felt like I had to work hard to get a deep breath. I was feeling worse quickly. I was taken to the ER in a wheelchair. I was put in a bed and hooked me up to monitors. I was left alone for a while. When the dr came in he checked me out and listen to my lungs. I had a hard time getting my lungs to expand. Doctor ordered a blood sugar test and it was below 100. Chest x-ray, EKG and blood work. He told me later that everything was normal. I was there for 2 hours before I felt like I could go home. I didn't receive any medication. I was able to breathe easier by time I left the hospital. I was thinking more clearly as well. The next day I was still feeling shaky and weak. I went to my PCP on friday and I was feeling normal by then.

Pfizer COVID-19 Vaccine EUA Patient presents 3/23/21 for medical monitoring of syncopal episode s/p COVID - 19 vaccine # 2. Lowered to the floor by vaccine staff. Patient reports symptoms of weakness, other wise states she ""feels fine"". Two additional syncopal episodes witnessed by myself when patient attempts to change position. Past medical history is significant for mild persistent allergic asthma, pre-diabetes, OSA, obesity and BPPV. Patient reports history of same reaction s/p previous vaccine. At a approximately 0837 patient was noted to have a worsening rash present to her face. EpiPen administered via left lateral thigh at 0838. EMS called to transport patient the ED for further evaluation. Treatment administered: epipen (lot 0FM406, exp 02/22) left lateral thigh at 0838. Upon arrival to the ED, patient's temperature is 98.8° F, heart rate 92-103, respiratory rate 30, saturating 99% on room air with blood pressure 164/91. The patient's laboratory studies were largely unremarkable. While in the ED, the nurse was getting ready to get the patient up to the commode when the patient started to ""not feel right again."" She asked her to administer the medications for allergic reaction and reports wall the 2nd medication was being infused, she felt paralyzed and unable to talk, although she was able to hear everything and was aware, she was unable to move or speak for a short amount of time. CT head with completed at this time and showed no acute intracranial findings. Chest x-ray unremarkable. EKG showed normal sinus rhythm with sinus arrhythmia, heart rate 80 and prolonged QT at 470. The patient was administered Solu-Medrol 125 mg IV, Pepcid 20 mg IV, Benadryl 50 mg IV, normal saline 1 L IV. Pt was admitted to hospital for observation. The patient was seen on the unit laying in bed with her husband at the bedside. She reports that she is feeling slightly better and hungry and has never felt at paralyzed/unable to speak feeling before and is very nervous about this. She was wondering if she had a seizure, although she reports feeling aware the entire time and did not lose bowel or bladder function. We discussed that that is not typical for a seizure, but even if we did an EEG at this time, it would not be able to tell us what occurred in the past. We discussed continue the Benadryl, Pepcid, and IV steroids for today and likely decreasing them tomorrow. We discussed the workup of syncopal episodes as well. The patient and her husband were agreeable to this plan. Patient was discharged from the hospital on 03/24/2021 in a stable medical condition. Patient was instructed to follow-up with her PCP in 1 week.

Pfizer-BioNTech COVID-19 Vaccine EUA The area received vaccination was sore, about two hours later became drowsy, had to leave work and go home, woke up around 5 p.m. body ached on left and right side, took Aleve for pain.. Overnight had chills, headache, next morning, took Aleve for pain. Whole body ached for about a week, headaches, lethargic, tiredness. About week and half later only ache in right arm, sore like I sprained it, still tender today.

total of 4 days tired/weak, and right arm sore (from thursday through sunday) early saturday morning had 4 hours of hallucinations, nausea and extreme vomiting, dizzyness ,loss of appetite slept for 12 hours on saturday and sunday after the 4 hrs of events listed above. still weak after feeling better on sunday afternoon

Speeding-like an extreme caffeine high. Couldn?t sleep for two nights. Blinding headache. Diarrhea. Chewed up inside of mouth until bleeding. On day three and symptoms slowly leaving. Now slight headache and extreme fatigue.

Within hours became disoriented, thirsty and achy. Next morning, arm was numb and fingers tingly, Achy, fever, nausea, headache, extreme thirst, disoriented. Extremely sore arm that I couldn't lift to my waistline without extreme pain.. Hard to dress/undress. Never felt so sick in my life!

Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt like fire ants; chills; no energy; tightness in chest; This is a spontaneous report from a consumer reported for herself. An 61-year-old female non- pregnant is unknown female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198), via an unspecified route of administration on Left arm on 02Feb2021 17:45 at single dose for covid-19 immunisation. Medical history included COVID-19, Congested Heart disease, and Penicillin allergy. The patient's concomitant medications were not reported. The patient experienced Hit with heaviness limbs pain in joints whelps all over body arms legs stomach back groin felt like fire ants chills no energy tightness in chest on 22Feb2021. Received Inhalers for breathing and steroids. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Recovering".

Following day: major headache; body ache; dizzy; coughing; short of breath; chills; nausea; extreme tiredness (stayed home from work) 2nd day: big headache; very light headed; some coughing; short of breath; nausea (stayed home from work). Not restful sleep. 3rd day: pressure headache; very light headed (went to work). Very tired at night. Hard time sleeping. 4th day: light headed; pressure in head; short of breath when going for a walk; hard time sleeping. Since 4th day, haven't slept well; light headed; on-and-off headache; at work but moving slow. Feels like when I returned from being out with Covid + double pneumonia 6/30/2020-7/23/2020.

Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.

Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible, No further information available

felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quenching, it was kind of weird; body jerking; feeling weird/felt like she was not herself/ she felt her body was trying to fight off something; heaviness in her legs; felt pain in her face; flinching; This is a spontaneous report from a contactable consumer(patient). The 61-year-old female patient received first dose BNT162b2, via an unspecified route of administration on 04Mar2021 (Lot Number: EN6205) as single dose for CIVID-19 immunization. Medical history included blood pressure issues from 2010 and ongoing, ongoing sinus issues which was diagnosed in 1973 or 1974, hypoglycaemia, reaction to tetanus shot several years ago. The patient's concomitant medications were not reported. She received postnasal drip started on 02 Mar2021 or 03 Mar2021 before the vaccine. She got the first Covid shot on 04 Mar2021. She wait 30 minutes because had reaction to tetanus shot several years ago. She had flinching, jerking and feeling weird 10 minutes after vaccine on 04 Mar2021. She and husband in holding area waiting. One time jerk so bad felt that she felt she had to lay down. She felt like she was not herself like she was out of body like there and she was not (AS REPORTED). She had a weird feeling after vaccine, she felt her body was trying to fight off something, felt like little bit out of body feeling, felt like she was going to hit the floor on unknown date. She felt lightheadness on 04 Mar2021. They checked her pulse and there was nothing with her heart rate. She does not know if it was an anxiety attack or not. She was nervous about getting the vaccine because it was so new. She felt this way for four days. On the fourth day that she felt she was coming around and on the fifth she felt herself. She has other underlying health issues and does not want the virus. She had heaviness in her legs, felt a pain in her face both on 04 Mar2021. The doctor wanted to rule out if she was having a stroke. She went to the ER, the ER kicked her out and did not find them. Her BP was 130/60 on 09Mar2021. They did blood work and an EKG(Electrocardiogram). They ruled out stroke. The doctor stated that the allergies could have made her feel dizzy but did not know about the twitching and jerking. She has lightheadness and dizziness because of other health reasons like sinuses, blood pressure and low blood sugar which these were before the vaccine. She had the normal EKG on 09 Mar 2021. There was unknown treatment received for events. Outcome of heaviness in her legs was recovered on 06Mar2021, of felt pain in her face, feeling weird, Dizziness was recovered on 07Mar2021, flinching, jerking was recovered on 04Mar2021, of felt like I was going to hit the floor was unknown. Case was assessed as serious.

received second dose of vaccine on 3/30. On 3/31 presents via EMS due to altered mental status and vomiting. EMS reports that she was found sitting in her van lethargic and actively vomiting. When EMS arrived they noticed that the patient had her fingers in her throat trying to induce vomiting. EMS reports EKG in sinus rhythm with HR 84, BP 178/106, and O2 sat 99% on RA. EMS did not notice focal weakness. Pt c/o HA and is noted on arrival to not be moving her LUE. I spoke with her daughter, who said she spoke to the pt on the phone at 10:45 am today and that she seemed normal at that time. She reports the pt does not have h/o cancer or heart disease and is unaware of any pt medication allergies. She reportedly received her COVID vaccine yesterday.

Dizziness, nausea, sleepiness, fog brain, temperature of 96-96,4 (taken with more than one thermometer), throbbing pain in left arm traveling to neck.

Massive headache, so bad I could not get out of bed. Fever of 102 that was gone the next day. Sore, tired, cranky. I still have a headache only I can function. It is a 4 today on a pain scale of 1 to 10. On April 1st it was so bad I could not get out of bed. I felt like my head was a giant toothache. I am not too sure about getting the second dose. I was truly frightened. I don't think I have ever felt that bad. Having kids was easier.

Vaccination was at 1pm. At 2am I got a horrible headache- stabbing pains in the back upper right ?corner? of my head. Couldn?t sleep. I would test the frequency every once and a while. I had 1-4 sharp pains every minute. I talked to my doctor at 2pm that day. She said I could take 800mg Ibuprofen/8 hrs. That worked. Had to do this for 2 days after my shot. I was very tired. I was fine after that.

Dull ache in left side of chest near breastbone.Unable to sleep. Began 9:30pm. Emergency room visit 2pm next day.

ears plugged and ringing; ears plugged and ringing; tongue sore; chills; muscle aches; weakness; joint stiffness; nausea; sharp pains in stomach and breasts; sharp pains in stomach and breasts; tightness in chest; fatigue; dizziness; impaired mental clarity; 102 fever/99 degree fever; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 15Mar2021 at 18:00 (06:00 PM) (Batch/Lot Number: EN6208) at the age of 61-years-old as single dose for COVID-19 immunization; administered to the patient in public health clinic/administration facility. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient's medical history included known allergies (unspecified). The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in the left arm on 22Feb2021 at 07:30 PM (lot number: EL9266) at the age of 61-years-old for COVID-19 immunization. The patient experienced 102 fever the night of 16Mar2021 (also reported as 16Mar2021 at 06:00 AM) with chills, muscle aches and weakness, joint stiffness, nausea, sharp pains in stomach and breasts, tightness in chest, fatigue, dizziness, and impaired mental clarity. On 17Mar2021, the patient experienced ears plugged and ringing, weakness, tongue sore, and impaired mental clarity. The patient had 99 degree fever during the nights of 17Mar2021 and 18Mar2021 thus far. The patient did not receive treatment for the events. The patient has not been tested for COVID post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).

I was fine for 3 days after the shot. On the 4th day I was tired in the morning and had a headache. During the morning I started becoming disoriented and very tired. I was at work. I sat down and slept for 3 hours not hearing anyone. When I woke up my coworkers said I moved about 10 things around where they didn't belong. Like a cactus in the fridge along with a soap dispenser. I don't remember any of it. I felt better when I woke up. When I got home I slept for 11 hours. I was a little groggy the next day. I was fine 2 days later.

3 days later began to feel very depressed, emotionally volatile, crying a lot. It has continued with some better days and some awful days, I am now 7 days post vaccination and today was awful. I have not had any major physical reactions other than some fog and headache.

5 MINUTES AFTER RECEIVING COVID VACCINE PATIENT REPORTED EXTREME DIZZINESS, AND A FEELING OF FULLNESS IN HER LEGS. SHE LOOKED PALE AND HER SKIN WAS CLAMY. GAVE HER SOME WATER AND 1 GLUCOSE TABLET (4GRAM CARBOHYDRATE). TOOK HER BLOOD PRESSURE AS WAS LOW AT 76/51, RECHECK 86/62, RECHECK, 86/58. ATTEMPTED TO CALL 911 BUT PATIENT REFUSED AND WANTED HER DAUGHTER TO COME GET HER. AT 3:54 PM SHE REPORTED THAT THE DIZZINESS WAS GETTING BETTER AND BLOOD PRESSUER RECHECK WAS 98/68. AT 4:01 HER BLOOD PRESSURE WAS 117/71 HR 73 THEN EVENTUALLY CAME BACK UP TO 128/80 AT 4:08PM. PATIENT LEFT AT 4:17PM. WILL FOLLOW UP WITH A PHONE CALL TODAY.

Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; temp of 101.6; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 01Mar2021 17:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included end stage renal disease (ESRD), high blood pressure and pulmonary hypertension; all from an unknown date and unknown if ongoing. The patient has no COVID prior vaccination and not tested to COVID post vaccination. There was no other vaccine in four weeks. Concomitant medications (reported as Other medications in two weeks) included clonidine (CLONIDINE), macitentan (OPSUMIT), minoxidil (MINOXIDIL), carvedilol (CARVEDILOL), and tadalafil (ADCIRCA); all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (lot number: unknown) first dose on 22Jan2021 at 02:45 PM right arm for covid-19 immunization. The patient also previously took Hydralazine and experienced allergies. It was reported that on 01Mar2021 08:00 PM the patient went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs., acting stiff and unusual behavior. The patient's daughter took the patient and had a temp of 101.6 was sent home Tuesday morning. The events resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered with sequalae (reported as with lasting effects). No treatment was given for the events. Information on the lot/batch number has been requested.

Did fine day of shot but next morning woke up felt like I got hit by a Mack Truck my left arm that I received shot swelled alot. I not experience that with previous flu shots or my pneumonia shot. I felt weird and sort of sick for 2 weeks.

In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As of this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday. Feel cold.

Began with soreness at the injection site and tiredness about 16hours post injection. Then I had body aches headache and low grade fever (99-100 degrees), about 18 hours after the injection. I had a rough night waking intermittently but all symptoms were gone when I woke at 10:30 am on 4/7/2021.

In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As if this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday

The first day she felt severe fatigue within hours. Went to bed and slept all day and all night. The next day woke up disoriented and weak. Called dr and dr recommended her call the ambulence. Went to ER and admitted to hospital. They said she had an infection and got on antibiotics. In the hospital 2-3 days and dismissed. Continue to have weakness and severe fatigue. Had 3 "MS hug"- muscles severely contract during this time- has to take muscle relaxer.

Arm soreness/pain impulses upon lifting of arm; pain about 10 minutes after injection; a fluttered feeling as if a fast heart rate; Difficulty lifting arm; This is a spontaneous report from a contactable nurse. A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jan2021 16:00 (Batch/Lot Number: EL9262) as SINGLE DOSE for COVID-19 immunisation. Medical history included diabetes, HTN (hypertension), Elevated Cholesterol, glaucoma, GERD (gastroesophageal reflux disease) and Known Allergies: black pepper. The patient's concomitant medications were not reported. The patient previously took Flexeril, codeine and fentanyl for all these drugs experienced drug hypersensitivity. Initially a fluttered feeling as if a fast heart rate, but 60 second counts revealed pulse regular and no more than 80. Arm soreness; pain about 10 minutes after injection. Continued despite use of Tylenol and heat packs. Difficulty lifting arm; pain impulses upon lifting of arm on 23Jan2021 16:00. The patient underwent lab tests and procedures which included heart rate was 80/min. The outcome of the events was unknown.

In order of occurrence: Chills/Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As of this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday. Feel cold. Note that after my shot I was out until about 4:30 pm. While out, I noticed that my face and neck felt hot and my neck was getting itchy, but I did not check it. After returning home, the itchiness, chills. etc. slowly increased until at 6:30 pm I was very

Headache, chills, nausea, fever that went higher as day went on, went up to 101 with taking ibuprofen, severe fatigue, could not stay awake more than half hour, fuzzy headed feeling, constant ringing in the ears , day 4 of effects couldn't catch my breath when walking more than 10 feet. Day 6 still have ringing in ears, some fatigue, breathing better but not 100%.

feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of hearing in right ear; when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear; muscle pain in injection site the first night after her dose; Sore Arm Left; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose bnt162b2 (PFIZER COVID VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 (Batch/Lot Number: ER2613) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received first dose of PFIZER COVID VACCINE last Saturday 20Mar2021. On 26Mar2021 the patient reported muscle pain in injection site the first night after her dose but it only lasted one day. Today 26Mar2021 noticed significant loss of hearing in right ear and feels a little dizzy. Noticed her voice was not quite right. She stated she felt kind of weird. When she eats fruit, she notices blocked feeling in her ear. When she talked she noticed an echo in her ear. She stated she was typically healthy. had this been reported and wondering when it will go away. On 29Mar2021 she stated she called last Friday and reported it because she was so frightened that she had lost her hearing in her right ear. She stated that after one day, her hearing half recovered and after two days, her hearing completely recovered. The patient experienced hearing loss in right ear from 26Mar2021 and sore arm left from 20Mar2021. She stated that she was 61, almost 62 and was very healthy, no medications, not sick. She stated her last vaccine that she had was in childhood. She stated that she doesn't get the flu shot and doesn't get the flu, nothing really. She stated that she had this vaccine for other people, for their concern, she was not worried. She stated the first night, she felt muscle pain in her arm and then she forgot about the vaccine, until Friday. She stated she realized when she searched sudden loss of hearing. She stated that it was all gone. She stated she thought should she have the second one, She stated she thinks it was fine. Clarifies that the first morning she noticed it when she got up it was a little weird, She stated she couldn't hear something, so she started searching this and said she better check it out because it said she needed to get treated sooner. She stated she thought what should she do and was in a panic and that was how she went on the internet and make the link. She stated she wanted to let Pfizer know that everything was back to normal. The outcome of event 'significant loss of hearing in right ear' and 'when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear' was recovered on 28Mar2021, of event 'muscle pain in injection site the first night after her dose' and 'Sore Arm Left' and was recovered on 21Mar2021, of other events was recovered on an unspecified date.

Approximately 12 hours after vaccines, chills, fatigue, nausea, weakness. These lasted 48 hours after start of symptoms 2nd vaccine symptoms were worse then previous vaccine and include having diarrhea. Still have activity intolerance

Threw up about an hour later 2pm. Threw up 2 more times in about a 3hr. total time frame. Achy and sore went to bed and slept till 4:30am. Felt better but still achy with a headache. Sun. feeling better.

Approximately 10 min after receiving vaccine, patient obtained a headache proceeding with tingling in both hands, difficulty swallowing, and feeling funny. She states as soon as she got it she developed an immediate headache, on her drive home she became lightheaded and had pins and needles sensation in her face and got a strange aura that lasted all her way home. She said for a while she felt like she couldn't swallow. She feels that she might have had a panic attack versus an adverse reaction to the vaccine and is declining any further evaluation.

Patient returns to Covid Clinic 3 hours after injection with her husband. CC: Feeling Funny, Weakness, and Shuffling Gait. Denies Respiratory involvement. Vital Signs Stable No Rash observed. Patient reports s/s started while shopping at shopping center three hours after injection. Reports history of Anxiety and reports taking Xanax the night before the Covid Appointment.

Anxiety thanks to crowds and fleeting initial dis-organization at the vaccine facility. Sore arm the evening of the injection and the next day. Joint/muscle aches and pains nights the 10th and 11th that interrupted sleep; took acetaminophen. Aches during the day and tired the 11th, 12th and 13th (so far). Strange taste in mouth, upset stomach 12th and 13th (so far). Not looking forward to second dose though happy to have started process.

I started symptoms late Sunday 4/11/2021, on Monday 4/12/2021 I became very lethargic, aches and pains, severe headache, all night has night sweats and chills., temperature reached 101.4 Tuesday 4/13/2021, felt disoriented, (this bothered me, I couldn?t even have a conversation with work or psychiatrist. I could think straight. Still headache, no fever. Very sleepy and achy.. started feeling better later in the evening. Wednesday, 4/14/2021. Hardly any side affects at all. Minor headache and sweats.

Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.

At approx. 9:22 AM on 4/2/21, I began having problems swallowing my saliva and felt my throat begin to close. I also began having problems breathing, began coughing and choking, chest pain, and dizziness. The nursing staff at Hospital immediately got a wheelchair and rushed me next door to the ER. The nurses had called ahead so that the ER doctors were ready to assist me. I was given Epinephrine, steroids, nubilizer treatments, Bendryl, IV fluids and oxygen. After some time I began feeling a little better but then the reaction restarted and treatments had to be re-administered several times. It was quite frightening. I also had a severe headache and tightness of the chest . The ER doctor believed that I should be admitted which was done on 4/2/21 and was kept thru 4/4/21.

Lightheadedness/dizziness the second day after receiving the shot (was fine the day after). Couldn't stand for more than a few minutes without support. The third day still a bit lightheaded/foggy, but much better than the day before.

April 12th - 4:30 pm and on - I was very tired and groggy April 13th - 7:30 am until 10:00 pm - I had a headache, nausea, no appetite, chills, fever up to 101.6, constipated and overall felt crappy - slept most of the day. I took Tylenol as advised by the medical center to help reduce the fever and aid injection site tenderness. April 14th - 7:15 am - 11:00 pm - I had a headache (not as bad as previous day, nausea, no appetite, chills, fever up to 99.4, constipated and overall felt crappy - slept a bit less than previous day. Between 2:00 am and 6:00 am, I believe the fever broke - sweats were consistent. I took Tylenol as advised by the medical center to help reduce the fever and aid injection site tenderness. April 15th - 7-20 am - current - All above listed symptoms have gone away. I also had a bowel movement twice today. I feel a bit tired but almost back to normal.

1 hour after shot numbness left side of face. 19 hours later extreme fatigue. 24 hours later dizziness. 11 days later extreme anxiety. 12 days later chills, body ache, fatigue, and anxiety. 13 days later severe ocular migraine.

after receiving vaccine started to get anxious due to environmental factors was feeling faint and wanted to lay down assisted to stretcher placed in trendelenburg snacks and water and juice provided bp elevated sat up bp cont to be elevated pt states having anxious thoughts about covid vaccine expressed to nurse bp elevated pt agrees to lay down and rest for a few minutes and close eyes deep breathing exercises enc to pt. per pt stress relieved after a few minutes and feeling better and requesting to leave, escorted to exit ambulated without difficutly, spouse awaiting in car and driving pt home. pt left at 1053 vs as noted VS 1015 bp 144/89 hr 72 rr 18 o2 95, 1020 bp 157/91 hr 80 rr 18 o2 98 1025 bp 177/107 hr 81 rr 18 o2 100 1035 bp 162/83, 1041 bp 137/87 1045 bp 155/84 1051 148/89

Pt reports feeling fuzzy (mental clarity wise) and a buzzing feeling since receiving Pfizer COVID-19 vaccine #1. Pt reports after receiving Pfizer COVID-19 vaccine #2, buzzing has gotten slightly worse. Pt reports when she takes a deep breath it causes her breath to catch and for her to cough. Pt reports no SOB or difficulty breathing.

left leg seriously cramped up around 11pm last night waking me out of sleep. continues to feel worse it is 9:50am . can barely move left leg

Swollen portions of hands, portions of feet, knees. Inflamed, red, hot, itchy and very, very painful. The issues move from area to area and seem to inflame fatty areas most. I thought this would go away and didn't document with pictures, like I should have. I now have a couple of pictures and will continue to do so. I've tried hot baths, cold packs, hot packs, elevating the area and topical relievers. I couldn't feel the heat of the pain reliever on the affected area. This has been absolutely debilitating and I've had to miss some work because of it.

Fatigue 4/16/2021-4/18/2021 Pain on left side of neck and behind ear 4/17/2021, 8:00AM-2:00PM Fog-Brain 4/17/2021, all day Low grade Fever 4/17/2021, 1:00pm-middle of the night when I woke up sweating, 99 degrees during the day time hours Took no fever reducing medications during this time.

This is a spontaneous report from received from contactable consumer. A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7534), via an unspecified route of administration on 24Mar2021 via an unspecified route of administration in top of left arm as single dose for covid-19 immunization. Medical history included Salpingo-oophorectomy (resection to remove an ovary and fallopian tube) in Mar2016 and an operation in 2016 for diverticulitis. Concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. No, she says this is her first vaccine, she has never even had the flu vaccine. Caller clarifies she is talking about the Pfizer BioNTech vaccine. Later in the call clarified as the COVID-19 vaccination. She is calling to report that she contracted COVID. She says she is so discouraged, she did everything right and she ended up getting COVID, she was shot in the arm, her family forced her to get it, 7 days later she was sick, so sick Wednesday(31Mar2021)/Thursday(01Apr2021), positive on Saturday (03Apr2021). She says she is been googling this, it has only been only 6 months, less than 6 months in. On 30 Mar2021, patient had experienced ill, Sneezing, coughing, choking, coughing up phlegm, Fever, Chills and aches. Patient says she did not get her second shot, she is supposed to go for it on 14Apr2021 but she suspects she had to get tested before she gets the vaccine. She says she does not know what to do. She says she is isolating herself and has her own bathroom. She says her card has a patient number and an ISS number. She says she is got this vaccine for society to get this vaccine rolling so we can be whatever the word is, for social status, to be in the cool club. Patient says she had no tests since she does not have a primary. The adverse event was not resulted in emergency room. The patient was resolving from the event COVID. At the time of reporting the outcome of the events were unknown. Additional information has been requested.

My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super watery bowel movement then went into clay like and drier consistency but still dark (I never had stool this dark).; I was dry/ I needed water; room seemed like it was so much further away, my stairs the spindles were larger in size, it was if I was high on something/feeling of peace, calm/high feeling; I was whistling in my breathing/ I had a loud whistle; feeling my eyes and hearing were sharp/ my eyes were changed eventually; had my eyes dilated; felt I like I was getting hemorrhoids/I woke up feeling like I had too much sugar; black stool; constipation; Chills; wanted to vomit; I got shaky; scares; There's a feeling of hardness in my lower abdomen and heart area (Belch); There's a feeling of hardness in my lower abdomen and heart area (Belch); reversed my beta blockers (it keeps it in the 50s) it went to 79; My energy was so much more.; The next day I gained 3.2 pounds then the next day lost 3 pounds; My injection site for the first 2 weeks,I had an itch/ extreme itch; injection site for the first 2 week/there's pain there on touch (no throbbing pain); My tooth broke; movement under my skin/shingles feeling; My skin is extremely dry; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. It was reported that the patient vision wasn't as good. She also had glasses to read (eyeglass wearer and ongoing) and behind her eyes they were dry one (left) mostly. Concomitant medications included unspecified beta blockers. On 11Mar2021, she got chills on the same day. Right as she got the shot, she wanted to vomit also and got shaky. On 12Mar2021, she woke up with whistling in her breathing for a few minutes then it was done. At the same moment, her eyes were changed eventually. She had mucus in my eyes as her vision wasn't as good and behind her eyes, they were dry one eye (left). So, watching TV wasn't as good and became bothersome. She later noticed, the black in here eye was taken up most of her eye (as if her eyes were dilated). Her eyes and hearing were sharp also now sharp as she was reading better (without my read glasses) and had to turn down the volume in her TV. She also felt like she was getting hemorrhoids for a few days but then it went away. She also had black stool, then constipation (harder stool) eventually went the day right after the shot (12Mar2021). Then around 5pm, she had feeling like she had too much sugar and was dry which she needed water. Once she sat down, her living room door seemed like it was so much further away, stairs the spindles were larger in size, it was if she was high on something. It was different nothing but this injection. She was also experiencing a feeling of peace and calm. As if nothing was wrong, no stress (stressing about something) she couldn't even think of- everything was gone, a calming effect. It was high feeling. The next day (13Mar2021), she had a super watery bowel movement then went into clay like and drier consistency but still dark (she never had stool this dark). In Mar2021, she also stated that there was a movement under her skin like a pre-herpes or a pre-shingles. She mentioned that she knew herpes and the movement under her skin was shingles feeling. Her skin was also extremely dry. On 17Mar2021 (a week after the injection), she woke up to my heart spasm. It was beating real fast (beating like right under her skin), no pain and heart attack but more than a heart flutter. She didn't know whether it was going to beat or stop. She also woke up with a loud whistle (louder than before) out of a dream. She stated that during the day she doesn't get the stressed, but in her dream, it was magnified and woke up in a violent vicious fury. She had 3 nights of this (uncalm coming into my dreams viciously, morbidly gross) started on 14Mar2021. The heart spasms come as a few seconds and goes away but that's happened twice which it scares her. She also stated that there was feeling of hardness in her lower abdomen and heart area (belch) in Mar2021. The injection almost reversed her beta blockers (which keep it in the 50s) it went to 79 (same as it was before she started taking beta blockers) but her blood pressure was normal 121/something (that was a good thing). She also mentioned that her energy was so much more while other people woke up early, cleaning up -would get sleepy and a little tired. But this (injection) gave her energy. Her injection site for the first 2 weeks also had an itch, that would come up (not constant) almost like a yeast infection which had an extreme itch. There's pain was there on touch (no throbbing pain) it took over a week before it was gone. She also mentioned that the chills were off and on for 4 days. The vaccine also did something to her weight as she was expecting to lose weight, but she didn't. One day, she gained 3.2 pounds then the next day lost 3 pounds. Her tooth also broke (but no pain in her tooth) even she had a sensation of her teeth being weak which she could feel it. Her tooth broke eating a tortilla chip and that's weird. She wanted to know if other people had called in with the symptoms that she had experienced. The patient recovered from breath sounds abnormal and constipation on 12Mar2021; cardiospasm, chills and vaccination site pain in Mar2021 while the remaining events were unknown. No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.

Started with slightly sore arm, and a headache, headache got worse, took advil, didn't sleep well, severe headache, muscle and joint pain, took more advil. Morning, felt like a flu, slight fever, body aches, joints, major pain trying to lift left (shot) arm. Not severe enough to seek medical attention.

Six days after my 2nd vaccine I had an anaphylaxis reaction. Out of the blue while I was driving my face started to burn like acid was rubbed on it. It got really hot and turned very bright red. Then my lips began to feel like they had been sunburned badly. Then my forearms both started burning and also turned bright red. I was very anxious. Had two bouts of diarrhea. All this occurred within about a 20 minute time-frame. I chewed up 4 children's Benadryl (50mg) and the redness, burning and anxiousness subsided mostly. My heart rat was still over 100 bpm even after 6 hours. (Usually my HR is 68-70 bpm). I slept for 12 hours and the next day seemed fine. This has occurred two more times since that first time. The 2nd reaction being 5 days after that first one and the 3rd reaction being 5 days after that. Same reaction, same treatment and same outcome.

Patient suffered a syncopal episode and confusion while under observation following her booster vaccination. Patient has a history of diabetic related emergencies but this syncope/confusion resolved itself while under the care of on site paramedics. Patient was transported to a hospital of her choosing.

DAY ONE April 15, 2021. On Thursday April 15th at 10:00 a.m. I received the first dose of the Covid 19 vaccine. They gave me the shot in my left arm. Within about 5 seconds, I started feeling nauseated and light headed like I was going to pass out. I asked to just sit there for awhile because I did not feel stable to stand up and go to the waiting area. I stayed seated for about 1-2 more minutes then the paramedics took me to the Medical area in a wheelchair. The paramedics checked my vitals. My blood pressure was 135 over ?? I don't remember. I told the medic my BP is normally 98/58. She said my BP was elevated. My pulse was in the high 80's. My temperature was 98.6 and my oxygen was 100. I started getting pain and pressure going up the back of my neck, into my head, eyes and ears. It was very painful and throbbing pressure. I felt dizzy and really high. It felt like I was floating on the top of the ceiling and the people were off in a distance. I was really woozy. I then got diarrhea. The nausea continued but I did not throw up. At times my thinking was spacey, so I talked to the paramedic to help me stay grounded. I narrated what was happening in my body. They did a glucose finger prick test because of my spaceyness, but it was normal. It was like my whole system was freaking out. I was there and then not there, feeling like I was floating. These symptoms continued for about 90 minutes and getting worse. The paramedics offered me to go to the hospital, but I thought eventually I would be fine. I did not want to go to the hospital and have a huge medical bill. At around 90 minutes, I started having pain in my heart left side, under my left breast on my left shoulder. The paramedics did an EKG and did not find anything but some irregular heartbeats. The heart beats felt like BA BOOM, then my heart would do a cartwheel. BA BOOM and another cartwheel. At this time, my husband arrived and took me to the hospital emergency room because the pain in my heart was getting worse. I stayed in the hospital emergency room until around 5:00pm on April 15th. They did another EKG and some lab work and did not find anything but low thyroid. I continued to feel drunk, nauseated, pain pressure and throbbing in my head neck, ears and eyes, diarrhea, and like I was High and going to pass out. The chest pain in my heart was off and on. It felt like muscle cramping in my heart, under my left breast and the left shoulder. I also got a pain in my left groin area, then behind my left knee. It was a sharp and throbbing pain for about an hour in each location, but eventually went away. While in the Emergency room, they tried to give me Ativan. I asked what it was for and they said Anxiety. I said I wasn't anxious; I was just having a reaction to my first Covid 19 vaccine. I said I did not want it because my body was already struggling to handle the Covid 19 vaccine. They said the doctor prescribed it. I said I had not seen a doctor, and they said it is protocol. The nurse then came in and wanted to give me a shot for nausea and I said no, I don't want any more chemicals in my body, it is really having a hard time already with the Covid vaccine. I went home, was wiped out, still feeling drunk/woozy/high, also nauseated, diarrhea, very dizzy, had a hard time walking. The pain, throbbing in my head, neck, ears and eyes was still there. By this time, I could not find clear thoughts, and could not make sense of things. I was very agitated and at the same time exhausted and only wanted to sleep. DAY TWO April 16, 2021 I woke up with a smashing head ache, neck ache, back ache and general feeling like Crap. The nausea and diarrhea were still there and had woken me in the middle of the night. I felt like a truck had hit me. I stayed in bed all day and tried to eat and drink as much as I could. I drank a lot of water that day. I felt horrible, but was able to stand without feeling like I was going to fall over. Had trouble finding clear thoughts at times. Still felt out of it and had chest pain off and on. Also had the BA BOOM heart beats and cartwheels in my heart. DAY THREE April 17, 2021 Very similar to day two. I felt weak, nauseated, diarrhea, pain all over, jittery, not able to have clear thoughts at times. It felt like my body was still on RED ALERT!!! I also had very shallow breathing on day 2, 3, 4 and 5. It tired me and I panted just getting up to go to the restroom. I am able to eat fine and keep food down. BA BOOM hear beats and cartwheels in my heart have lessened. DAY FOUR April 18, 2021 I felt a little better and made the mistake of thinking I was getting over the reactions and did too much. Shortness of breath. DAY FIVE April 19, 2021 I feel horrible again, Nausea is really strong as well as the diarrhea. I am feverish, sweaty and shaky. Shortness of Breath. Tight in my chest. I just took my temperature and it is normal, although I am hot, sweaty, feel feverish and shaky. I am exhausted. The headache is still here as well as the pains in my neck, ears and eyes. The aches in my body are still here. I have no energy. A wave of emotions is also here and I am weepy and crying. This is no fun. I am able to eat food OK and drink lots of water to counteract the diarrhea. DAY SIX April 20, 2021 Shortness of breath, very tight in my chest, having to take Benadryl and use my rescue inhaler to keep my breathing open. Feverish, chills, shakey, hot. Temperature 97.0 Blood pressure 90/66 Pulse 70. I feel like crap, just wiped out.

Sore shoulder for three days-no treatment Bodyaches- for three day-Tylenol, rest, water Headaches- for three day-Tylenol, rest, water Slept all Saturday following, most of Sunday, Some of Monday Insomnia Sunday night about four hours, Monday about two hours. Internal external mouth sores. Still healing from outside sores Brain Fog. Took about three weeks for brain fog to go away from first to second shot. Still have brain fog from second shot which what I am reporting on here.

This was my second COVID dose, it felt completely different from the first one, which was given at a different pharmacy. When it was being injected, it felt like the vaccine was pooling in my arm and the injection took much longer than the first one. My arm felt heavy within 30 minutes of getting the vaccine. About two hours later, I could not lift my arm more than 10% without terrible pain. I could not sleep even taking Advil. After three days, the intensity lessened some, but I still cannot lift my arm certain ways without a lot of pain and it is keeping me awake as it just aches. I cannot lay on that side either, as the pain becomes intolerable.

Chills, restless sleep amd headache. Chills ended in the morning, 6 hours, headache and fatigue lasted till evening, 12 hours +/-

severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started swelling; rapid breathing, couldn't control her breathing; heart rate it got faster; started getting confused; shaky; wheezing; swelling of her throat; blood pressure dropped; This is a spontaneous report form a contactable consumer reporting for herself. A 61 years old female consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; NDC number 59267-1000-01) on 29Mar2921 at 14:15, in left upper arm, for COVID-19 immunisation. No other vaccines were given on the same date or within 4 weeks. Medical history included allergic to hamsters (she found out that this one had the Chinese Hamster Ovary cells and she knew she had problems with those things), allergic to prednisone (crazy rash, itching), allergic to a lot of different things, sinus infection. Family history included allergy (the whole family had allergies). Concomitant medications included unspecified antibiotics for sinus infection (but it had cleared up by then) and unspecified allergy shots (but not a vaccine). The patient just wanted to report that she had a severe allergic reaction to the vaccine on 29Mar2021. Symptoms began minutes after getting vaccine. The patient experienced getting lots of saliva started with a couple of minutes of getting the shot, tongue started swelling, rapid breathing, couldn't control her breathing, heart rate it got faster, started getting confused, shaky, wheezing, swelling of her throat, blood pressure dropped, all on 29Mar2021. On 30Mar2021 the patient experienced sore arm and neck pain but she thought that was more of a vaccination saying it was working. Clinical course of the events included the following information: the patient had to stay for a while since she had allergies normally. She started getting lots of saliva and she thought that was her body saying, she did something, not a big deal. Around 15 minutes, she was at a grocery store, she started walking around, her tongue started swelling, rapid breathing, she couldn't control her breathing and heart rate, it got faster. She started getting confused, shaky, it wasn't too good. She made her way back to the place where the injections were done, they were trying to get her to use her epinephrine (EPIPEN). She took a diphenidramine (BENADRYL) while walking around looking for her husband and then took another and was wheezing. She thought BENADRYL would have helped. She should have taken her EPIPEN looking back, she thought BENADRYL would help. They heard wheezing, they contacted the other pharmacist, who contacted EMS then they came and took her to the emergency room on 29Mar2021 in the afternoon. When she was wheeled in, the doctor met her in the hall and he said they could give her a steroid shot. The patient stated she was allergic to prednisone, she got a crazy rash, itching, it's not just prednisone, it's an allergy. She got the shot at 14:15 and she was at the hospital by 15:00. The patient thought she was there for 5 hours and then she was sent home. Her blood pressure dropped. The only one she saw was 114/39 but her husband saw it went even lower than that. At the emergency room, they had the automatic thing strapped on so they watched her until it started going back up again. The vaccine shot was probably the easiest shot she had ever had. She had never had any problems. She did not research it very well in the beginning because she thought they should be good. The patient was told to not get the second vaccine. The events also required physician office visit. Allergic reaction symptoms resolved on 29Mar2021 but the swelling of her throat and heart rate lasted about four days, until 02Apr2021. Neck pain resolved on 01Apr2021. Sore arm resolved on 03Apr2021 or 04Apr2021. Blood pressure dropping resolved on an unspecified date in 2021. Information on the lot/batch number has been requested.

Woke up early the night of the shot with severe pain in left are below shoulder where shot was given. My arm has been painful to move..I thought would eventually go away but never did. Three weeks later still very painful and makes my job even more painful to do. It's a continual ache and hard to move.

I had done some weight lifting on Wednesday morning, the day before dose 2. May have aggravated a nerve in my back but had no sensation of this until acute pain from mid upper back across shoulder and down right arm. Began exactly 12 hours post vaccine. And woke me from deep sleep. Could not get relief for several days until I contacted provider and was given Flexeril and Aleve. Could not lay down or sleep due to position of nerve in my back. (Vaccine administered in Left arm. ) Have never had a problem previously like this in my back. I exercise regularly. I surmise that if this nerve was aggravated, the inflammation induced by the vaccine made this worse where no vaccine and I would not have had a problem. Friday followed with typical side effects of lethargy and tiredness. Experiencing slight mobility issues in right arm post 13 days vaccination.

Having injection site pain; Nausea; Can hardly hold her head up; She slept all day yesterday, and slept all night; She just gets hot; Feeling unwell; blood pressure was out of control; lymph nodes are not as bad, they are hurting; She is having hot flashes; Tiredness/ she is still tired; Muscle and joint pain; swollen lymph nodes under arm; muscle and joint pain; Chills; Headaches; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old-female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: CR8732 or LR8732) first dose on 03Apr2021 08:30 on right arm at single dose for COVID-19 immunization. Medical history included ongoing High blood pressure (Has had a long time), Breast cancer (Has had 6 years) and covid in Feb2021. History of all previously immunizations was No. Prior vaccincations wtihin 4 weeks was No. AE's following prior vaccinations was No. Concomitant medications included anastrozole (ARIMIDEX, strength 20 mg) for breast cancer (Has not taken the last 3 days, Did not want to take with the shot), bisoprolol fumarate, hydrochlorothiazide (BISOPROLOL HCT) for Blood pressure (States that she was taking 5-6.25mg and increased dose to taking 10 in the morning and 5 at night) and ongoing Vitamins. States that in Feb2021 had Covid and had gotten over that and was discharged. States that she might have had mild Covid and with all of the variances coming out, she wanted to get the vaccine. States that she got her first dose on Saturday (03Apr2021) and didn't know if she hadn't waited long enough. Caller states that she has been having terrible reactions. Has been having injection site pain but even had that with the flu shot. States that she has been experiencing tiredness, headaches, muscle pain, chills, joint pain, and lymph nodes under her arm were swollen where she got the shot. Has also been experiencing nausea and can hardly hold her head up. States that she slept all day yesterday, and slept all night. Woke up this morning feeling a little bit better, then the side effects took a hold of her again. Caller states that cancer meds made her gain weight and hasn't been able to get rid of it. Noticed Tiredness yesterday (04Apr2021) when she woke up. States that she had the vaccine on Saturday the 03Apr2021 at 8:30am, started to have headache that night. States when she woke up yesterday (04Apr2021), she started experiencing all of the other symptoms, tiredness, headaches, muscle pain, chills, joint pain, and lymph nodes under her arm were swollen where she got the shot. States that when she woke this morning, had thought everything was a little better but, then it hit her again. Clarifies she is still tired, and the headache still has not gone away. This morning (05Apr2021) she is having hot flashes, not so much the chills. The chills are still there but not nearly as bad, she just gets hot. She has been experiencing nausea and feeling unwell. States that the lymph nodes are not as bad, they are hurting but, not as bad. States that it is hopefully doing what it is supposed to do. States that she has been taking only Tylenol but has not taking it yet today. States that she is super scared to get the second shot. If this happened with the first shot, is terrified for the second shot. States that she has been taking Tylenol every four hours and is such a lightweight that she has only been taking one Tylenol every four hours. Caller states that she is supposed to be back 24Apr2021 for second shot but does not know if she can go through with it. States that this was recently increased when her blood pressure was out of control when she had gotten Covid. States that she was taking 5-6.25mg and her dose was increased dose to taking 10 in the morning and 5 at night. States that she is not taking as prescribed but she was too chicken to take the 10mg. States she will be back to see her doctor on 16Apr2021. States that she hates taking any medicine. Tests: States that she had bloodwork done Friday (02Apr2021) but has no idea of the results. States she will be seeing her doctor 16Apr2021 to go over the results. Vaccination facility type was Hospital drive up. Vaccine administered at military facility was No. No events required to ER. Caller states she has contacted her doctor to find out about her future vaccination. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Headache; nausea; could not sleep for 6 days; Heart Racing; Body shaking; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208), via an unspecified route of administration, administered in arm right on 12Mar2021 09:30 (at the age of 61-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma, blood pressure and cholesterol; all from an unknown date. The patient had known allergies. No covid prior vaccination. No other vaccines in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); chlorphenamine maleate, phenylpropanolamine hydrochloride (NASAMEX); simvastatine; ibuprofen; losartan; and furosemide (FUROSE); all were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 10:00, the patient experienced chest pain, rapid heartbeat, high blood pressure, dizziness, felt like she was going to faint and couldn't walk so dizzy. Her heart raced/heart racing for 5 days, headache, nausea and could not sleep for 6 days and body shaking. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events. Double the dose of losartan for blood pressure. Not tested covid post vaccination. The outcome of the events was recovered.

Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headaches. It has been 36 days now and the headaches are still there but not as severe. The ear ringing tho; It is extremely irritating; Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headaches. It has been 36 days now and the headaches are still there but not as severe. The ear ringing tho; This is a spontaneous report from a contactable consumer (patient). This 61- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: ER8733), via an unspecified route of administration, on 01Mar2021 at 12:00 AM (at the age of 61-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was reported as "other" and anatomically located on the left arm. Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection, Lot number EL9265,) dose 1 on 08Feb2021, for covid-19 immunization. No allergies to medications, food, or other products. The medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021, she experienced Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headaches. It has been 36 days now and the headaches are still there but not as severe. The ear ringing thou is still present 24/7. It is extremely irritating and there is nothing i can do to make it better. Treatment was not received for the adverse event. The clinical outcome of the events was not recovered. On 05Apr2021, the patient was tested for COVID-19 via Nasal Swab since having the vaccine, with a negative result. No follow-up attempts are possible. No further information is expected.

when woke up today 4/27/21 at 7am, exhausted, muscle ache, headache, fever 101.3, foggy brain, 2 new symptoms that I didn't get with first vaccine: VERY thirsty, bloodshot eyes

Presented to emergency department with complaints of fatigue, cough, diarrhea, epigastric pain, confusion, and malaise. Patient was admitted for hyperglycemia, suspected UTI and COVID-19 infection. Patient reported symptoms started around the same time of vaccination. Patient is still admitted at time of writing.

I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.

First shot was fine - no symptoms. Second shot - severe flu type symptoms, headache, body aches, chills. Had trouble sleeping the following night of the vaccine with nightmares, unable to sleep at all, just plain felt miserable and had difficult time getting out of bed.

Global amnesia. Husband took me to specialty hospital ER. Cat scan and exams done. Taken to their facility for observation, telemetry etc overnight

Shortly after receiving the vaccine, Client complained of lightheadedness. She noticed it when she started to get up to leave as she had sat there for 30 minutes. She does admit to having some anxiety about getting the shot as she has had an anaphylaxis reaction to both pyridium and macrobid requiring ED intervention. She carries an epipen with her. She is on Metoprolol as she throws quite a few PVCs. BP at 11:55 am 186/88- pulse-64 and ox reading 97%. Encouraged to drink some water to hydrate as has not drank much today. BP at 12:05 pm BP=184/84 and light headedness has resolved and able to leave. Card with contact information given to Client if any other side effect should be experienced. Encouraged her

After my vaccine, I passed out. I went to the hospital for three days and they told me I had an ocular migraine. I also had a post concussion syndrome and was out of work till 04-12-2021 with nausea and severe migraine headaches. I still have headaches today and I am on migraine medication.

At 11:15 p.m. (10 hrs. after shot), I woke up nauseous, sat up in bed and felt weird, got up and made it to the foot of bed and passed out. When I came to, had my husband get me a cold rag, but then I felt diarrhea hit, I crawled to the hall to the bathroom, stood up and had the uncontrollable shakes so bad the whole toliet shook with me. After I finished in bathroom I went back to bed and literally shook for 1 1/2 hours and was up most of the night. This was my 2nd shot. On the 1st shot it made me feel like I was in a fog, like when you pass out and come to and your not all there. Took 3 hours to shake that one. I don't know what is in the freakin thing, but my body cant take this kind of stuff and I WILL NOT be doing any more of this quickly made, quickly approved vaccines. Count me out for any further ones. I'M DONE !!! I have never taken the flu shot ever so I WON'T be doing any more of these no matter how much the CDC pleads with me

Patient received first dose of Pfizer Covid 19 vaccine on 03/12/21 in am and by 8pm same day, she was experiencing numbness and tingling in left arm, from acromian process to hand/fingers. She also report pain in arm, especially at night which wakens her. she is able to relieve the pain by stretching and extending left arm above her head. She has received second dose of Pfizer Covid 19 vaccine on 03/30/21 in right deltoid and has not experienced these symptoms. The symptoms reported in left upper extremity continue through today. 04/30/21.

severe vertigo; fall down on the floor; nausea; horrible spinning; vomited; dizzy; generalized weakness; brain fog; a little tired; a little off; Fatigue; sore arm; couldn't eat; couldn't open her eyes; nystagmus; couldn't walk at all without help; This is a spontaneous report from a contactable consumer, reporting for herself. A 61-year-old female patient received the second dose of the bnt162b2 (BNT162B2; Lot Number: EN6208; Expiration Date: Jun2021), via an unspecified route of administration in the right arm on 19Mar2021 at 13:30 at a single dose for covid-19 immunisation. Medical history included ongoing celiac disease diagnosed in 2012 and has been gluten free ever since, allergies, and anxiety. Concomitant medications included zolpidem tartrate (AMBIEN) taken for sleep; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergies; alprazolam (MANUFACTURER UNKNOWN) taken for anxiety; vitamin d nos (MANUFACTURER UNKNOWN) taken for immune system health; and magnesium (MANUFACTURER UNKNOWN) taken for health. The patient previously received the first dose of the bnt162b2 (Lot number: EN6203) at 61 years of age on 26Feb2021 between 5:15PM and 5:30PM in the left arm at a single dose for covid-19 immunization and the flu vaccine (INFLUENZA) for immunization 15 years ago and experienced arm was sore. There were no other prior vaccinations within 4 weeks. On 19Mar2021, the patient experienced sore arm. On 21Mar2021, the patient experienced a little off, fatigue, brain fog, a little tired. On 31Mar2021, the patient experienced severe vertigo, fall down on the floor, nausea, vomited, horrible spinning, generalized weakness. In 2021, the patient experienced couldn't open her eyes, couldn't eat, nystagmus, could not walk at all without help. On an unknown date, the patient experienced dizzy. The events, severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning, required emergency room and physician office (video) visits. The patient was hospitalized for severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning from 31Mar2021 to 02Apr2021. The clinical course was as follows: the patient received the second dose on 19Mar2021 and she didn't really have any bad side effects, a sore arm, and a little tired on the second day, maybe a little off but was fine. 12 days later she was vacuuming and had severe vertigo, she was down on the floor, just horrible spinning, horrible nausea and laid on floor and vomited all day. Her doctor told her to go to the ER. They did all kinds of tests with unknown results on an unknown date and she could not open her eyes for 2 days, she was so violently spinning with vertigo, they gave her fluids. She went in on Wednesday and by Friday she was a little better, she could open her eyes, still had spinning and vertigo. It was like nystagmus, her eyes were, she just really couldn't open her eyes for the doctor, had generalized weakness and couldn't walk at all without help in the hospital. The only time she moved from one position was to go to the bathroom with assistance. In the ER, she could not get up out of bed the first night they were trying all ways of catharizing her. She could not even get out of the bed with the help, they had to carry her to the CAT scan with negative result on 31Mar2021. She had slightly improved but still had vertigo and she was not vomiting anymore, that was only the first couple days. She was sent home with medications for dizziness and nausea but they didn't do anything. Two weeks later she was still dizzy, had vertigo, it was way better than it was, she can open the windows a little bit but she was basically in a dark room for like the first week and a half. Not violent like it was the first couple of days. The events were further described as: she was a little sore on 19Mar2021, 20Mar2021, 21Mar2021, and maybe the 22Mar2021 her arm was still sore. She clarified the sore arm pretty much ended on the 22Mar2021. She was surprised she felt fine on 19Mar2021 and 20Mar2021 and on the evening of 21Mar2021, in the middle of the night between 20Mar2021 and 21Mar2021 she felt a little off and a little more tired. On 21Mar2021, she didn't feel great, fatigued and brain fog but was fine after that. She began feeling a little off and a little tired early morning on the 21Mar2021. That was pretty much gone by the 22Mar2021. The feeling tired and a little off and the brain fog and fatigue went away 22Mar2021. She vomited constantly, started suddenly and violently and was incapable of moving, all she did was vomit and lay on the floor. It was a complete 360, she was fine vacuuming a minute before and then suddenly got dizzy and went down and could never get up. She had to be taken from upstairs in her house and transported to the hospital. She was not really experiencing the nausea now, she was not completely herself but she can eat, she couldn't eat for the first couple of days and was on IV fluids and once she got out of the hospital was able to eat a little and now eating almost normally. It took a week to eat normally and she couldn't eat holiday dinner on 04Apr2021. From 31Mar2021 to 10Apr2021, every day the nausea has slightly been improving. She was not quite herself and still has vertigo and was making herself eat her meals. She vomited 30 times and in the hospital they gave her an IV to stop that and never vomited in hospital, maybe once in the ER. She confirmed the 31Mar2021 was the last time she vomited. She had not recovered completely from nausea. She used be running around all the time, she would walk 10 miles per week to exercise, yesterday she had a mammogram scheduled and she was just so wiped out for doing something for the first time and had to lie down for the whole rest of the day. She was hospitalized from 31Mar2021 until the evening of 02Apr2021 when they let her out. She was given medication for nausea and dizziness didn't do anything. She was given ondasetron (ZOFRAN), 4 mg and meclizine. Because of her weakness, the patient was checked to see if there was any brain bleed or brain stem problems that would explain the vertigo and did not find anything. The tests were negative for any brain problems on an unknown date. Lab data included: blood levels: low on vitamin d (probably because she was not absorbing nutrients as well) on an unknown date, endoscopy: unknown results on an unknown date, and MRI: negative on 01Apr2021. Therapeutic measures were taken as a result of severe vertigo, fall down on the floor, nausea, horrible spinning, vomited, and dizzy. The clinical outcome of the events, severe vertigo, nausea, generalized weakness, could not open her eyes, nystagmus, could not walk at all without help, was recovering. The clinical outcome of the events, fall down on the floor, horrible spinning, dizzy, was unknown. The clinical outcome of the events, a little off, fatigue, sore arm, brain fog, and a little tired, was recovered on 22Mar2021. The clinical outcome of the event, vomited, was recovered on 31Mar2021. The clinical outcome of the event, could not eat, was recovered in 2021. No follow-up attempts are needed. No further information is expected.

Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the back kind of by the lungs; She has been sick; Her mental status was also affected; What scared her was not feeling like she was getting enough oxygen; Nausea; Body pain/flu-like body pain in her muscles over her shoulders; Out of it; Pain in her back where her lungs are; Problems breathing/Her breathing still almost feels labored; Hot and cold sweats; Dizzy; Shaky; Weak; Tired; Headache; Anxious; Fever; Itchy; Arm hurt; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 61-year-old female patient received first dose BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (Batch/Lot Number: TW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cancer, pneumonia, pain in her lungs, smoker and arthritis. The patient's concomitant medications were not reported. The patient experienced what scared her was not feeling like she was getting enough oxygen on an unspecified date, problems breathing/her breathing still almost feels labored on 11Apr2021, arm hurt on 09Apr2021, pain in her back where her lungs are on 11Apr2021, hot and cold sweats on 10Apr2021, dizzy on 10Apr2021, shaky on 10Apr2021, nausea on 13Apr2021, body pain/flu-like body pain in her muscles over her shoulders on 11Apr2021, out of it on 11Apr2021, weak on 10Apr2021, tired on 10Apr2021, headache on 10Apr2021, anxious on 10Apr2021, fever on 10Apr2021, itchy on 09Apr2021, feeling like maybe there is something wrong with her spleen on an unspecified date, the pain is in the left side of the back kind of by the lungs on an unspecified date, she has been sick on an unspecified date, her mental status was also affected on an unspecified date. Patient had the first dose of the Covid Vaccine on 09Apr2021 and gradually her arm hurt, she had hot sweats, she felt dizzy, was shaky, had nausea, and had body pain. The one thing she is concerned about was she had pain in her back where her lungs are and she was having problems breathing. She has a little bit of that still. She has also been out of it. Her breathing still almost feels labored, and this past weekend she thought she would go to the emergency room. Her main concern is this awful pain in her back while she was having problems breathing and getting enough oxygen. She felt weak, dizzy, and shaky. She got scared. She has been sick, she had cancer a long time ago. What scared her was not feeling like she was getting enough oxygen. The pain is in the left side of the back kind of by the lungs. It goes directly from the front to the back. On Monday it started feeling better. Today it is so much better. She will feel like she is not getting enough oxygen or giving a full breath and then this in her back. She remembers having pneumonia years ago and having pain in her lungs. That's why she knows the pain is in the back of her lungs. She has to say she is a smoker. She slowed down and couldn't smoke this week or during that. She kind of quit, that's her reality now. The pain comes and goes throughout the day but it is not as bad. She didn't have this shortness of breath and other things until a couple days after she got the vaccine. It gradually came up on her. She was not having trouble breathing, it was more slightly labored. It was not profound, just there. Sometimes when she is speaking after a while she gets tired and will have to take a moment and take a deep breath. It is so much better. She called her primary care physician and was anxious, and all he said was she would feel effects for 2 weeks. He wasn't very helpful. Her arm hurt the day that she had the shot. Even today there are little bits of pain but very light. 09Apr2021 through 11Apr2021 was when everything really hit. It was hard to lift up her arm. It was a little pain, it was no big deal. She would have the AC on and blast it when she had the hot and cold sweats. She was using napkins because she was sweating profusely. It felt like she obviously had a reaction to the vaccine. It's normal she guesses. She didn't expect it for the first dose. The 11th, 12th, 13th, and 14th it was really bad. Her whole body was sweating and would get wet. She'd be hot and then cold. She was anxious because she was having problems breathing. She still gets a little bit of hot and cold sweats, but nothing compared to what she went through. As the days go on she is slowly getting better. She was dizzy not just during the day, at night she couldn't sleep because of it. She has gradually gotten better. Yesterday she tried to do some gardening but felt so weak she had to come back inside. When she gets up she feels weak and a little bit of lack of air. She has labored breathing. She was real itchy. The shakiness, dizziness, and anxiety all came on and were horrible. She doesn't know if the nausea was because she couldn't eat and had to take her regular medication. It was very light nausea. She had flu-like body pain in her muscles over her shoulders. Her headache was major too during all of this. The headache is something that comes and goes still. It is a weird kind of headache. She had a fever and got like flu all over body pain. She doesn't know how to explain how she felt out of it. She doesn't know if it was the fact she was so sick. She had a feeling of did she do that. She couldn't make decisions. She would need to take the garbage out and go back to the garbage and think what did she come here for. Her mental status was also affected. The weakness gradually got really bad, and she still hasn't recovered from it. She still feels weak and tired when trying to do things. She was tired the day after she got the vaccine. The first day she thought it was nothing and she was fine. Gradually it got real bad when she was sick. She didn't feel that flu-ish feeling but was weak and tired. She got dizzy and she had the brain fog thing. She was having really bad headaches during the same time. The weakness and tiredness go hand in hand. She takes a mineral for her thoracic spine, but she takes that more for elderly arthritis. She doesn't have any conditions that she thinks played a role. She has been feeling like maybe there is something wrong with her spleen. Took Tylenol for her fever. Mentioned fever would go away and come back. The patient underwent lab tests and procedures which included body temperature: 102, 99 and 100.1 (unit unspecified) all on unspecified dates. Therapeutic measures were taken as a result of fever and itchy. Outcome of the event problems breathing/her breathing still almost feels labored, arm hurt, pain in her back where her lungs are, hot and cold sweats, dizzy, out of it and headache was recovering. Outcome of the event fever was recovered on 13Apr2021, itchy was recovered with sequelae on 14Apr2021, body pain/flu-like body pain in her muscles over her shoulders was recovered on 16Apr2021, nausea was recovered on 16Apr2021, shaky was recovered on 19Apr2021. Outcome of the event weak and tired was not recovered. Outcome of all the other events was unknown.

Mild/moderate loss of bladder control Off balance Injection site pain Headache/ stabbing pain in left temple area,a little in the right temple/"spacey" feeling Lower back pain/General muscle weakness Chills/ low grade fever Nausea Congestion/cough Lasted 24-48 hours

Day after injection- diarrhea for two days and sore arm. Five days after injection left arm so sore I couldn't use it. Prescribed Motrin 600. Pain gone in two days.

bled a bit; pain in left finger joints/ joint aches; sudden heaviness in arm; chills; severe fatigue; over all unwell/uneasy feeling; Nausea started about the 5th hour; feeling feverish, but never had a real fever; odd little pains in the left side of her neck; tension type headache; foggy; blood vein and possibly a nerve was hit; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Feb2021 (lot number: EL9265) at 10:00 at single dose for COVID-19 immunisation. The relevant medical history included arthritis, breathing issues - asthma/copd still being tested, hypertension, liver issues and known allergies: Ct contrast, Dilaudid, Flagyl combined with doxycyline or cephlexinc. Concomitant medications were reported as none. At injection, a blood vein and possibly a nerve was hit. She felt the nurse followed all proper protocol for finishing the injection and notifying RN in charge. On 03Feb2021 at 2:00 PM, the patient had immediate pain in left finger joints and sudden heaviness in arm within a couple of minutes. It bled a bit. She was still having some issues with the hand, but the injection site was fine. She was concerned about the number of symptoms, the severeness and the length of time they had lasted. This was very worrisome and unexpected from all other accounts by others and everything she had read on the first vaccine. She was feeling 'off' within 2 hours, by the 4th hour She had developed chills, severe fatigue and over all unwell/uneasy feeling. Nausea started about the 5th hour and she started feeling feverish, but never had a real fever, odd little pains in the left side of her neck, but that subsided. Developed tension type headache, joint aches, foggy. This continued for about 4 1/2 days. Unable to function without Tylenol every 5hr. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

Client began to feel anxious and shaky after receiving the vaccine. Fire Rescue at the scene to evaluate client. Clients BP was elevated but all other vitals stable. Client states hx of high BP and did not take BP meds this morning. Client began to feel much better and blood pressure came down. Per Fire Rescue no further evaluation needed. Client exited park at 2:30pm.

Second blood clot that traveled to her brain which caused her to have a stroke; Blood clot in her right leg; Weight Loss from 258 pounds, down to 208 pounds, back up to 214 pounds.; She has to learn how to walk again, she is in a wheelchair now; Having Problems Swallowing from the Stoke; Speech went down to 25% and now she is at 50%, because of the Stroke; high blood pressure; slept five days; Arm was Sore; Body was Sore; Diarrhea; Slept and was Totally Exhausted; This is a spontaneous report received from a contactable consumer (husband of the patient) and a contactable other healthcare professional. This consumer reported similar events with different doses of the same product; this case refers to dose 2; only this case is serious. A 61-year-old adult female received the second dose of BNT162B2 (solution for injection, Lot EL3246 expiry information not provided) as a single dose via an unspecified route on 30Jan2021 at 13:45 (at 61-years-old) for COVID-19 immunization. Relevant medical history included ongoing seizures (1964; began at 5 years old, minor seizures; under control in 1984, possibility configuration it is the right cocktail), and wound on her left leg (that was being treated by a wound doctor for the last 7 years). Concomitant medications included gabapentin; 300mg three times a day by mouth (6am, 2pm and bedtime) ongoing from 2014 for nerves; valproate semisodium (DIVALPROEX; 500mg two tablets in the morning and one tablet at 6pm ongoing from 2010 for seizures furosemide 20mg every 48 hours (odd days); States she takes it to reduce swelling (diuresis)on the leg wound leg; states he gives it to her on the odd day of the month from an unspecified date; metoprolol (50mg) one tablet twice a day (6am and 6pm), for Blood pressure management; ascorbic acid, zinc (VITAMIN C WITH ZINC; 500mg/50mg) once daily from an unspecified date for an unspecified indication; acetylsalicylic acid (ASPIRIN) 81mg once daily from an unspecified date for an unspecified indication; and pramipexole 0.5mg once daily at 6pm ongoing from an unspecified date for seizures. The patient previously received COVID-19 immunization with the first dose of BNT162B2 (solution for injection; Lot EL1284) on 09Jan2021 (at 61-years-old) and experienced arm was sore, slept for two to three-days, body was sore, and diarrhea. The consumer reported that on 30Jan2021, the patient experienced her arm was sore, her whole body was sore for about five days, she had diarrhea for five days, and she for slept five days and was totally exhausted. The consumer then reported that on 22Feb2021, she developed a blood clot in her right leg. The reporter explained that her leg swelled up and turned dark blue, almost black. The consumer reported that the patient was immediately rushed to the hospital. Caller states they did all sorts of tests and confirmed she had a blood clot in her right leg. States she was hospitalized from 22Feb2021 through 26Feb2021, so for five days. Caller states the leg went back to normal color, the swelling went down and she felt good. Caller states they came home on 26Feb2021, and she was up moving around, and everything was wonderful. On an unspecified date in Feb2021, around the time of the first blood clot, the patient was diagnosed with high blood pressure. Caller states on 12Mar2021 she had a second blood clot that traveled to her brain which caused her to have a stroke. Caller states when they got to the hospital they said she had a stroke from a blood clot that was somewhere in her system and it traveled to her brain. Caller states she was hospitalized from 12Mar2021 through 16Mar2021 when she was released from the hospital. Caller states she was too sick to go home so she was transferred to Rehab Center. She was there from 16Mar2021-27Apr2021. Caller states on 27Apr2021, she was transferred for rehab. Caller states at the center they only give rehab once a day for 30 minutes and he only works five days a week. Now she gets three hours of physical therapy a day and it is seven days a week. States they are working to get her to walk again and she is receiving speech therapy. States she has to learn how to walk again. Caller states her lowest weight was 208lbs, and they weighed her in yesterday and she was at 214lbs. Caller states with the stroke when she was at the hospital, they put her on baby food because she was having problems swallowing. While at rehab center she went from baby food to mechanical food. On 27Apr2021 she went to regular food. Speech because of the stroke went down to 25% and now she is at 50% and she is also getting one hour of speech therapy at hospital. Caller states they recognized it is important to get as much therapy as possible in the first 90 days, they call it a boot camp and patients are limited to 90 days to repair the damage. After 90 days, that is it. States that is why it was important to transfer her to hospital to heal and get back to normal. Caller states she is in a wheelchair and they are trying to get her to stand up. Caller states at the hospital they were able to get her to take 2 steps. At Hospital they were able to get her to do special training and he was able to get her to take 4 steps. Caller states he has no idea where she is with the walking right now. States she did not do anything on the 27Apr2021, because that was arrival date. Therapy started yesterday on 28Apr2021 at Hospital. The consumer also reported that the patient's current weight is 214 pounds, from 258 when she took the shot and down to 208 pounds on an unspecified date in 2021. Treatment for the events included occupational, physical and speech therapies, as well as apixaban (ELIQUIS), rivaroxaban (XARELTO), and spironolactone 25mg once a day; takes in the evening at 6:00p.m. ongoing from 12Mar2021 for hypertension. The outcome of the events arm was sore, body was sore, diarrhea, and slept and was totally exhausted and slept five days was recovered on 04Feb2021. The outcome of the event blood clot in right leg was recovered on 26Feb2021. The outcome of the event second blood clot that traveled to her brain which caused her to have a stroke was recovered with sequelae on an unspecified date in 2021. The outcome of the event Having Problems Swallowing from the Stoke was recovered on 27Apr2021. The outcome of the events speech went down to 25%, back up to 50%, and weight loss from 258 pounds, down to 208 pounds, back up to 214 pounds was recovering. The outcome of the event high blood pressure was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021484454 PFIZER (Same reporter/patient/different doses/events)

TIA/Mini stroke; Blood pressure went up to 240/130; Loss of memory; Everything is foggy; Lips and tongue started tingling; Stinging lips; She is not taking the second vaccine. She reported that the card has a reminder to return date to go back in April and states she did not go and is not going to get the 2nd dose; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in left arm on 21Mar2021 10:30 (at the age of 61 years old), 1st dose, single for COVID-19 immunization. Medical history included diabetes and ankle problem from an unknown date and unknown if ongoing, and bariatric sleeve from 2018 to an unknown date. Concomitant medications included all her normal medications and medications for high blood pressure (not specified). The patient reported that she was administered with the first dose of the vaccine on 21Mar2021 and on the same day, her lips and tongue started tingling during the observation period after the administration. The patient also reported a few days later on 02Apr2021 that she had a transient ischemic attack (TIA), which was also described as mini stroke. The patient also reported that she has not been administered the 2nd dose. She is not taking the second vaccine. She reported that the card has a reminder to return date to go back in April and states she did not go and is not going to get the 2nd dose. She also complained since day one on 21Mar2021 about the stinging lips and tingling tongue. She was hospitalized with the mini stroke, she was admitted 02Apr2021 and discharged 04Apr2021. Another thing was loss of memory on 02Apr2021, from the time the ambulance picked her up and took her to the local hospital she recalls that, but she doesn't recall that hospital to being transferred 6-7 hours later. She stated she doesn't recall anything, it's like a blank. She was transferred from one hospital to another and the 1st hospital she recalled getting there, her mom worked there, but she doesn't recall the 6 hours in between or the ambulance ride to a different town. She stated everything is foggy. She still has problems remembering, it's better but she still has problems remembering like if she is talking to somebody and gets sidetracked, she doesn't recall what she was saying. The patient reported that her blood pressure went up to 240/130 on 02Apr2021 when the ambulance picked her up. She reported that since 2018 her blood pressure was always normal until after the vaccination. The patient underwent a heart monitor, brain scan EEG, an MRI and echocardiogram/EKG on an unknown date, with unknown results. The outcome of the events "Stinging lips" and "Lips and tongue started tingling" was recovered on 02Apr2021, and unknown outcome for other events.

Sunday after 2nd dose of vaccination (May 9) I started having numbness and tingling in my arms legs, face and neck and experiencing nausea. When I sleep at night if I lay in one position for too long my day starts to burn in that area. I am having trouble sleeping. The nausea continues to come and go as does the numbness and tingling and burning issues at night. It seems to be getting worse every day and I am getting tired and weak.

itching; brain is on hold; localized injection site urticaria; generalized prickle sensation; Bilateral Wheezing; hoarse voice; Generalized Urticaria; Generalized erythema; coughing so bad she vomited: first dose; broke out in a rash; croupy cough; rhinorrhea/runny nose; This is a spontaneous report from a contactable nurse (patient). This 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in right arm on 22Mar2021 08:00 (lot number EP7534) at single dose for COVID-19 immunisation. Medical history included Latex allergy, Penicillin allergy. Patient previously experienced allergies with allopurinol (ELAVIL) and amitriptyline. Concomitant medications included triamcinolone acetonide (KENALOG), famotidine (PEPCID), and multivitamins. Patient reported that when she first got her vaccine, she broke out in a rash on 23Mar2021, nothing productive, no fever no nothing. She took care of the rash with a little prednisone, antihistamines. She stated the day she got her first one was 22Mar2021. Her arm got red the next day 23Mar2021, nice little whelp around it, her arm started getting kind of bumpy and a little itchy, then she noticed it on her back and her chest then around her waist, just patches, whelps. She started on Hydrocortisone and it just never went away. Then after, started 29Mar2021 or 30Mar2021, she got a croupy cough, the coughing lasted a few weeks, it ended sometime in the end of Apr. She thought it was seasonal allergies, but the coughing was so bad she was actually vomiting from it. She stated she actually thought she had COVID but she didn't run a fever and didn't lose taste or smell, just the way she was coughing and it was in her chest. She stated just some coughing, no fever, no production of anything, just coughing, very raspy. She had a dose pack, she took it, took Benadryl, Antihistamines, the rash was still there, but not as bad. She states the first one stayed on her back and chest and a little bit on her arms, back, arms and so forth. Then the second shot (in her left arm, LOT: ER8732), she was head to toe in a rash and she got the second shot 12Apr2021 in the left arm at 08:00. The rash never even went away, it just got worse. She stated it was serious enough because of all the medication, Benadryl, antihistamines, Atarax. The patient also experienced runny nose in Mar2021. She stated it's like her brain is on hold since the shot. She stated the coughing so bad she vomited started the first of Apr. The cough had just gotten so hard, no matter what kind of cough medicine she took, it just did not help it. She stated flat out croupy cough. Cough Medicine: she just did the Mucinex DM for the congestion and she did Dayquil and Nyquil that type of thing. She stated when she got on the steriods, that did help with that. She stated she was on her fourth dose of steriods, oral steriods, she had one IM dose. She had to go to doctor to get an IM steriod and other three have been oral. The treatment medication included: Hydrocortisone (EXP: Nov2023, LOT: 20W319, NDC:0031713-03): Cortisone 10. It's the cream she's been using, the itch relief cream, to help relieve the itching. She's been using regular Hydrocortisone cream, she's used a lot of that. Prednisone (LOT: UJ200503B, EXP: Mar2022, NDC: 42806-400-21) pack currently on, she stated this is the third pack of tabs. Prednisone shot: she went to the doctor office and got a prednisone shot the week before last, so last Wednesday on 28Apr2021 or 29Apr2021. Two previous steroid packs. Benadryl (LOT: P83332, EXP: Jun2021): 25 mg tablets, takes two of them about every 3-4 hours. Loratadine (LOT: 0BE2611A, EXP: Oct2021, NDC: 49348-818-56): 10 mg tablets, she takes them first thing in the morning, by mouth. She stated it's been tough between taking magnesium sulfate (EPSOM) salt baths and avena sativa (OATMEAL) baths. Patient was not seen in the emergency department, no hospitalization required. Respiratory: Bilateral Wheezing, Dry cough, hoarse voice, rhinorrhea. Dermatological/Mucosal: Generalized Urticaria, Generalized erythema, generalized pruritus with skin rash, generalized prickle sensation, localized injection site urticaria. Patient did not receive any recent vaccines for any other conditions prior to the event being reported, did not receive any recent vaccines for SARS-COV2 other than the Pfizer- BioNTech COVID-19 Vaccine prior to the event being reported, did not receive any other vaccines around the time of Pfizer- BioNTech COVID-19 Vaccine vaccination. Lab data included COVID test: unknown result on unspecified date. The outcome of event rash, itching was not recovered, outcome of cough, vomiting, rhinorrhoea was recovered in Apr2021, outcome of other events was unknown.; Sender's Comments: Based on information available, the reported serious event rash was likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to the temporal relationship and known safety profile of this product.

Patient has had Bells Palsy 2 times prior. 1976 H1N1 vaccine / 2009 after having been infected with H1N1. No Fever at all during 14 days May 12- facial pain, body aches, head aches. May 15- all symptoms continued facial swelling, loss of feeling to touch of face. Pain traveling down neck. Left side of face dropping. Hands very cold and cramping. May 17 - body aches and headaches leave. All other symptoms and facial pain continues. Tingling of skin on knees begins. May 21 - knees and thighs begin to feel numb and tingly. This feeling of not right continues to increase and spread. May 24 - all facial pain increased. Legs and arms tingly and numbing feeling unsteady. May 25- flushing and rash appears. Arms are heavy and all other symptoms continue.

Patient became rigid and fell down and could not get up, she can no longer stand unassisted. She has become incontinent and now has to where a diaper, and leans to her right side while sitting and standing. She cannot focus for very long. And she becomes rigid and stiff for periods of time. She is no longer able to bath herself or care fir her basic needs. Even with intense therapy hasn?t reached her baseline.

severe brain fog; intense cramping; she got red really fast and almost a strange itching inside her body; felt she had Covid; Mild diarrhea; body aches; fever; Headaches; This is a spontaneous report received via medical information from a contactable consumer (patient). A 61-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 30Mar2021 (Batch/Lot Number: ER8737) at the age of 61-year-old, as single dose for covid-19 immunisation. Medical history included ongoing thyroid disorder has had for years, ongoing hypertension started about 8 years ago, ongoing immune system disorder ( Her spleen has been removed, and she is immune compromised). The patient was immune compromised and has no spleen and she had Covid and has Covid long haulers. The patient's concomitant medications were not reported. The patient received the second dose of Covid vaccine received on 20Apr2021, at 09:00, right arm injection. After the 1st dose of Covid vaccine she felt she had Covid. Mild Covid again, for about 4 days. She experienced fever, body aches, and some mild diarrhea the same day of vaccination. The patient did not confirm if she just felt like she had Covid again or tested positive for COVID-19 after first dose. She had diarrhea until she received the second dose of the vaccine then got ulcers in her mouth, body swelling, and had headaches with both doses. The patient stated that fever started after the 1st shot, within 4 hours, It was fast. She was sitting with a friend and she got red really fast and almost a strange itching inside her body. She told her friend she needed to lie down. Her friend told her she didn't look good. It happened so quick. It started on 30Mar2021 and she recovered completely. Body aches started on 30Mar2021 but not until the evening and lasted until it ended with the fever. She recovered completely. She was a long hauler and this was a whole different ball of wax. Patientdidn't feel it when she had Covid. Mild diarrhea started in the middle of the night on 30Mar2021 and she doesn't think it ever ended. It spun around, It was now constant diarrhea and continues from the first dose. It waswater and with intense cramping and is constant. She is on the BRAT diet. It won't hold so she is living on Gatorade and white rice. Headache started with the first dose. The headache came in after the first dose and was very mild. It left just like the symptoms did. The headache started when the fever started and it started quickly and it hasn't left. Patient also complained severe brain fog. The patient experienced felt she had covid (suspected covid-19) on 30Mar2021 with outcome of unknown, mild diarrhea on 30Mar2021 with outcome of unknown , body aches on 30Mar2021 with outcome of recovered , fever (non-serious) on 30Mar2021 with outcome of unknown , headaches on an unspecified date with outcome of unknown, severe brain fog (feeling abnormal) on an unspecified date with outcome of not recovered , pruritus on 30Mar2021 with outcome of recovered , intense cramping on an unspecified date with outcome of unknown.

Severe pain in upper neck, left shoulder, left arm; Severe pain in upper neck, left shoulder, left arm; Severe pain in upper neck, left shoulder, left arm; pain to left shoulder and left arm where the shot was given/Severe muscle pain on injection arm; Left wrist ache; was not sleeping; severe muscle pain; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 10:00 (Batch/Lot Number: EN6208) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included nerve injury from an unknown date and unknown if ongoing, intervertebral disc operation from 2019 to an unknown date, nuchal rigidity (Can't turn neck to the left past a certain point) from an unknown date and was ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2m (Lot number: EN6198) on 12Apr2021 (at the age of 61-year-old) for covid-19 immunisation; the past drug includes naproxen which worked well. The patient developed pain to left shoulder and left arm where the shot was given a week later/ Severe muscle pain on injection arm, on an unknown date in May2021, severe pain in upper neck, left shoulder, left arm on 07May2021, experienced left wrist ache, was not sleeping on an unknown date in May2021. It was reported that patient used ice packs on it and taking Naproxen around the clock, but nothing touches it. Starts to feel like she was getting better, but really was not. The patient had no cold or flu symptoms. It was reported that patient visited chiropractor on 01May2021 for this crick in her neck. States she did not have COVID arm and did not have redness or swelling on the injection arm. It was also reported that patient had severe muscle pain on an unknown date in May2021. The patient has been taking Naproxen (Kroger brand, Formulation: 220mg caplets, NDC: 30142-617-90, Lot: 9ER0418, Exp: Dec2020) at a dose of three caplets in the morning. A couple of nights did two caplets 12-14 hours later; Lidocaine Patches (NDC: 0603188010; Lot: 74098; Exp: Jun2017; Formulation: 5%, 700mg patches) at a dose of patch on last night where the main part of the pain was at, which was the injection site, put one patch on the left arm and one patch on the upper part of the left shoulder near her back, left patches on overnight, about six hours. The outcome of the events pain to left shoulder and left arm where the shot was given/Severe muscle pain on injection arm, Severe pain in upper neck, left shoulder, left arm was not resolved, left wrist ache was resolved on May2021 and was not sleeping, severe muscle pain was unknown. No follow-up attempts are needed. No further information is expected

body swelling; Swollen joints; Ulcers in her mouth; Migraine headache; Constant diarrhea; Brain fog; This is a spontaneous report from a contactable consumer reporting for herself. A 61-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine in Hospital, via an unspecified route of administration, administered in right arm on 20Apr2021 09:00, at 61 years of age, (Batch/Lot number ER8737) as single dose for COVID-19 immunization. Medical history included thyroid disorder from an unknown date and ongoing (she has had it for years), hypertension started about 8 years before this report and ongoing, immunodeficiency from an unknown date and ongoing, her spleen has been removed and she is immune compromised and has had COVID. The patient reported that after the first dose of Pfizer-BioNTech COVID-19 mRNA Vaccine administered on 30Mar2021 at 09:00, she had mild diarrhea, body aches, fever and headaches and she felt she had COVID. The patient's concomitant medications were not reported. In Apr2021 the patient experienced body swelling, assessed as medically significant, swollen joints, ulcers breaking out inside her mouth and a 24 hour migraine headache. Ulcers started about 3 days in from the 2nd dose, they come and go. She keeps them at bay by using Listerine. She understands that whatever is happening in her lower gastrointestinal tract is coming up into her mouth. The patient added she is a neuro-muscular therapist and had an understanding of how her body works. The body swollen started a week after the shot (also reported as immediately after the shot). It continues at the time of the report and it is persisting. The patient stated "she has a little bit of COVID brain". Moreover, the mild diarrhea after the first dose changed to constant diarrhea after the second dose. It is water and with intense cramping and is constant. She reported she is on the BRAT diet. "It won't hold so she is living on Gatorade and white rice". Over the past week, her joints in her hands and in her body have become swollen. Horribly swollen to the point she couldn't get her pants on because her knees and ankles were so swollen. Her hands last week started swelling and the pores around her joints look like blisters. The patient added she has had severe brain fog since an unknown date which was ongoing at the time of the report. The headache has not left as well, the outcome of all the events was unknown at the time of the report. The patient has not been to the Emergency Department or her Physicians office, but was going at the day of the report. No follow-up attempts are needed. No further information is expected.

Pt reported severe anxiety and syncope when receiving injectable medication and blood draws. Pt was agreeable to receive vaccine and a plan was made ahead of time to administer to her in her vehicle with the seat laid flat. Upon receiving the vaccine, the pt immediately stated, " I don't feel good" and began to hyperventilate and complaint of tingling in all extremities. Pt then vomited and an EMS crew on standby was notified to evaluate the patient. The patient was eventually transported to the ER due to near syncope and hypotension.

Began to feel hot.; Upper extremities became to feel tingly or prickly internally/ tingling traveled to my legs; Antsy, fidgety and felt like bouncing off the walls.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP7534) via an unspecified route of administration in left arm on 16Mar2021 at 07:15 (at an age of 61-years-old) as a single dose for COVID-19 vaccination. Medical history included allergic to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 16Mar2021 at 07:30, approximately 10 minutes after the vaccination the patient had upper extremities felt tingly or prickly internally and began to feel hot. Then the tingling travelled to his legs, almost like the feeling when legs fall asleep. About an hour later felt like drank a pot of coffee, the patient was antsy, fidgety and felt like was bouncing off the walls. The clinical outcome of upper extremities felt tingly or prickly internally and began to feel hot, tingling travelled to the legs, almost like the feeling when legs fall asleep was recovered on an unknown date; while for the event antsy, fidgety and felt like was bouncing off the walls were recovered on 16Mar2021. No follow-up attempts are needed. No further information is expected.

Cough; Body aches; I am tired because I have been sleeping a lot; Injection site pain; Chills; I am tired because all I do I have been sleeping a lot; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0187) via an unspecified route of administration on 29May2021 in upper right arm as 1st dose single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 30May2021, the patient experienced cough, some body aches, she was tired, she got the pain at the injection site which she knew was common anyway, little bit of chills but nothing major. She was tired because all she did was sleeping a lot. She just wanted to know if she could take amphetamines (treatment), if it could help alleviate some of those side effects. She wanted to know if it was safe to do that or not. The outcome of all events was unknown. Consumer was informed about Pfizer Medical Information Department. Information on Lot/Batch number was available. Additional information has been requested.

Around 7:00-8:00 that evening, approximately four hours after recieving the vaccine, I started having shooting pain in my head. It was mild at first, then harder and more frequent as the evening went on. It did that until late the next morning and was completely gone by around noon. This wasn't a 'headache' or migraine. It was shooting pain like none I had ever had in my head. I had a knee revision years ago and it also affected the knee through the night with that same type of pain. I wasn't as concerned about the knee, but, the head was concerning. I didn't report it because I didn't know I had to register to check in.

She is worried it is a kind of blood clot.; She is worried it is a kind of blood clot.; Swollen lymph nodes in right leg; This is a spontaneous report from a contactable consumer(Patient). A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 23May2021 as 2nd DOSE, Single for covid-19 immunization. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity. No family medical history reported. The patient's concomitant medications were not reported. Patient previously took historical vaccine of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm left on 02May2021 as single dose for covid-19 immunization. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. It was reported that, on 26May2021, after getting the second dose of the Covid vaccine, she had swollen lymph nodes in her right leg. She was worried and asks what to do and She asked if she needs to go to Urgent Care. she is worried it is a kind of blood clot. She asks if Pfizer will call her doctor and then call her. All she had were swollen lymph nodes. They are getting big and big. She confirms they are getting bigger. No relevant tests reported. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

feeling very very low and depressed and moody/ sadness, not myself/ events worsened yesterday its seems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on the left arm on an unspecified date (at the age of 61-years-old) as second dose, single dose for COVID-19 immunization. Medical history included ongoing depression (that was reported as currently and have this for several years on medication). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), bupropion hydrochloride (WELLBUTRIN SR), quetiapine, atorvastatin (LIPITOR), amlodipine, levothyroxine sodium (SYNTHROID) and hydrochlorothiazide; all taken for an unspecified indication, start and stop dates were not reported. On an unspecified date in 2021 (reported as Saturday, yesterday), the patient experienced feeling very very low, depressed, moody, sadness and not herself. The events were reported as seemed to have worsened. The patient was not sure if the events were reaction to the second vaccine she had on Thursday and stated that it may be the vaccine was effecting. The event seriousness was unspecified by the reporter. There was no investigation assessment. No treatment was given as a result of the events. The outcome of the event was not recovered. The patient was querying if this could be experienced by the medication that she was taking. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

he received Pfizer vaccine 2/5 and got symptoms a few weeks after the vaccine. She experienced a lot of chest pain at work and went to healthcare facility and was diagnosed with pleurisy. She received steroid treatment and a steroid shot and then received another 3 rounds of steroids - this was through February, March, and April. She saw a pulmonologist 5/20 and CT scan done again and CXR. She was diagnosed with pulmonary edema and elevated calcium levels. She was started on some pain medicine at that time and a steroid. After she came off steroids, was in a lot of pain and had to stop working. Diagnosed with recurrent pericarditis.

Stomach cramps increased; Upset stomach; Memory is not good/sometimes she remember things that amazes her and sometimes she cannot remember what happened yesterday; Pain in lower abdomen; This is a spontaneous report from a contactable consumer (patient) and physician. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0167), dose 2 via an unspecified route of administration, administered in Arm Left on 29Apr2021 12:00 as 2nd dose, single dose for COVID-19 immunization; palbociclib (IBRANCE), via an unspecified route of administration from Apr2016 (Batch/Lot number was not reported) to 27May2021, at 125mg caplets oral with water for 21 days on and seven days off once a day for stage IV metastatic breast cancer. The patient's medical history and concomitant medications were not reported. No patient history. Family Medical History Relevant to AE(s): None. No other products. History of all previous immunization with the Pfizer vaccine considered as suspect: None. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0153), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date 12:05 as 1st dose, single dose for COVID-19 immunization and had stomach cramps. The patient stated that she was on Ibrance. The patient stated that she had second shot on 29Apr2021. Since the second vaccine, she had so much trouble with her stomach. The patient stated that this had been an ongoing thing. Her stomach cramps increased, and she had pain in her lower abdomen. The patient stated that she had the first shot three weeks before the second shot and had stomach cramps. The patient stated that stomach would not settle down. The patient stated that she would get some good days. The patient stated that last week on Thursday that she was in downward spiral and could not get out of it. The patient stated that she was being careful with what she ate. The patient stated that she stopped the Ibrance. The patient stated that this week was her seven days off and she would call today to ask for next month but wanted to take a reduced amount. The patient stated that when she saw her oncologist that she asked if people ever stop taking Ibrance and was told no that if one has a reoccurrence that it may not work as well. The patient stated that she did not ask for a reduction at that time but intends to. It was a temporary stop. The patient stated that this was more about Ibrance than the vaccine. The patient stated that she had pain in lower abdomen that started 10 days ago. The patient stated that she gets upset stomach from time to time but that it had been pretty constant since the first week in May. The patient stated that sometimes she remembers things that amazes her and sometimes she cannot remember what happened yesterday. The patient stated that other factors were involved (memory) at that time that her husband was ill. The patient stated that the stomach cramps started again 6 days after second vaccination and resolved last week. Recovered with lasting effects of upset stomach. The patient stated that she changed from capsules to caplets in 2020. The patient was treated with Mylanta. The patient stated that she had a video call scheduled with her nurse practitioner. Is eating soft foods and keeps drinking water. Relevant Tests: None. The event did not result in Emergency Room/Physician Office. The outcome of the events stomach cramps increased was recovered with sequelae, pain in lower abdomen, upset stomach was recovered, memory is not good/sometimes she remember things that amazes her and sometimes she cannot remember what happened yesterday was unknown. Follow-up attempts are possible. Further information is expected.

Pt received first Pfizer COVID vaccine dose at approximately 0800 on 5/27/2021. Injection administered in left deltoid. Pt states that she took two Tylenol before going to bed the night of 5/27/2021. Felt fine prior to going to bed except for injection site pain. She was awakened by chest pain, muscles pain, joint pain and swelling and malaise at 0200 on 05/28/2021. She states she did not have a fever and felt cold but no chills. States the chest pain lasted about 30 minutes. Unable and afraid to go back to sleep after this episode. Joint and muscle pain resolved after about 2 days.

flushing on my face three times like heated /top of my head to chin and is like some covered it but it was more like flush; felt little bit weird; Heart racing; felt little off; head is drawling; hives; This is a spontaneous report from a contactable consumer. A 61-years-old female consumer (patient) reported for herself that she received first dose of BNT162B2 (COMIRNATY, solution for injection; Batch/Lot Number: EN6206; expiry date, UPC number and NDC number were reported as unknown) via an unspecified route of administration on 20Mar2021 in left arm as a single dose for covid-19 immunization. Medical history, other products, investigation assessment and concomitant medications were not reported. On 20Mar2021, the patient experienced slight reaction in morning after 10 mins of first shot which included flushing on face like three times and it was heated (from top of head to chin and was like some covered it). Her doctor said flushing was like something that drained out of her face like heat. She was not able to describe it. 15 mins after taking the shot she felt little off and weird, had hives, her heart was raising (doctor couldn't recognize her pulse), and her head was drawling. The events occurred 2 to 3 times in a row. She stayed at the vaccination centre for 30 minutes and after that she felt fine. She reported that she had little diet and too much caffeine half the day, received first dose and had mild reactions but was fine after an hour. She asked if she could take second dose and does the events get worse after second dose. The patient did not receive any treatment. The action taken in response to the event for BNT162B2 was unknown. The outcome of all the events was recovered on 20Mar2021. No follow-up attempts are possible. No further information is expected.

Feeling some nausea almost daily. Feel like marbles are between my skin (like on my foot, hand, underarm, head) but cannot feel them it just feel like something is there. High allergic reaction to my cat. (have had my cat for 6 years, now got hives). Just overall not feeling well. Feel itchy like I'm about to have a reaction. Like heightened response to allergens.

Persistent vomiting from 3am to about noon on Monday. Fever of 38.4 ' C. Headache, chills, fatigue. Slept most of the day. Took acetaminophen when able to drink. Drank ginger tea and ate dry toast in the evening. Tuesday, HA controlled with Acetaminophen and Ibuprofen. Able to eat and increase fluids. Consulted with my PCP who suggested I enter my information. Feeling stronger as time passes. I believe another nights sleep will help.

swelling and joint pain in the little finger on left arm; swelling and joint pain in the little finger on left arm; She got a bruise at the injection site; It bled a little bit when she put it in; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231), via an unspecified route of administration on the left arm, on 28Dec2020 at 14:15 at a single dose for Covid-19 immunization. Medical history included environmental allergies, she has allergies and can have an asthmatic attack from cat dander and perfume, blood pressure (abnormal) and sleep (disorder). Concomitant medications included ongoing lisinopril for blood pressure, colecalciferol (VITAMIN D), acetylsalicylic acid (BABY ASPIRIN), paracetamol (TYLENOL). The patient previously took novocaine but was allergic. She got all this information when she got the vaccine on Monday at (place name) in (state name). It tells all the side effects from the first injection. She wanted to report that it is the same arm that she got the vaccine in. She has swelling and joint pain in the little finger on left arm. It says you can have joint pain, but nothing about swelling. She thought she better report it. This was her first shot. She is supposed to get the second one on 18Jan2021. She wanted to make sure she can take it. She received the vaccine on 28Dec2020. She laid around that day. Today is the first day she doesn't have arm pain and swelling at the injection site. It was the first time she has had arm pain. She has never had that with flu shot. The arm pain started within the 15 minutes she was observed. It hurt like hell until that day. She got a bruise at the injection site. It bled a little bit when she put it in. Swelling and joint pain in the little finger on left arm: she doesn't know if it was later that day. She can't remember. She really noticed it yesterday. She has never had joint pain or swelling. She doesn't have any problems with arthritis. Now her little finger is bigger than the rest of her fingers. It hurts because of the swelling. She doesn't want to take anything. It might be fluid. She has a high pain tolerance. She keeps bending it thinking it will get better. It isn't as bad, but its still swelled up. At first she thought it was better, but it is still pretty swollen. To her this is a reaction. She was thinking if she took paracetamol before, it wouldn't hurt as bad, but she can't remember if she took it that morning. She takes 500mg before bed for the heck of it at night. It helps her sleep better. She has allergies and can have an asthmatic attack from cat dander and perfume. They think she was allergic to the preservative in the flu shot, but she has never had any trouble with the flu shot since. She has environmental allergies. They thought she was allergic to Novocaine once at the dentist office. Who knows, it only happened once. She's been to the dentist many times and who knows what they injected and why she reacted that way. She felt like she was going to pass out. They don't give it to her anymore. She doesn't know what was in it. She is worried since this vaccine is emergency authorization. She doesn't want to get the next one and have a worse reaction. She is not sure if she should be worried. The events of swelling and joint pain in the little finger on left arm were assessed as medically significant. Outcome of the event of 'swelling of fingers' was not recovered, the other events were unknown.; Sender's Comments: There is a reasonable possibility that the event joint pain was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the event swelling with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

At 12 hrs after injection vomiting and severe chills for an hour. 15 hrs after injection severe body aches for an hour. 18 hrs after injection was mild-moderate headache and moderate tiredness and confusion for another 4-6 hrs.

My body had started itching and I didn't know why. I had not eaten anything new or changed any shampoo or soap. Finally on Thursday night I realized maybe it is the shot that is giving me all the itching. My whole body was flushed I kept scratching my arms and legs, especially around my ankle, knee, under arm and goin area. I took an allergy pill and called Kaiser and spoke with an advice nurse. she mentioned that taking an allergy pill will relief some of the itching. I fell asleep around after midnight normally I go to bed around 9:30. I also called pfizer and explained and the person took all my information and symptoms.

Confusion, Headache, Myalgia, fatigue, chills Narrative: Felt "loopy" with sharp vision initially. Over 3 day period developed varying degrees of chills, headache, muscle aches. Fatigue on first day.

shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever for 4 days, horrible chills that were just debilitating; ached everywhere/ severe aches; site soreness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration at left upper arm on 18Dec2020 at single dose for COVID-19 immunization. Medical history included auto immune problems, diabetes, thyroid condition, all ongoing since age 28; pemphigusvulgarism since Sep2020 and ongoing. No concomitant medications. Patient is a frontline worker. She received the vaccine on 18Dec2020 at (Name) where she works. 9 days later she got very ill. she didn't know if it's unrelated. She wanted to know if there is anything she need to be watching out for in order to get her second vaccine on Friday. She was so sick and she did have some autoimmune problems. She was really healthy. On 26Dec2020, she had a 103 degree fever for 4 days, horrible chills that were just debilitating. She was just shaking. She ached everywhere, she had severe aches since 26Dec2020. She got tested for Covid and it was negative on 28Dec2020, she had no cough and no vomit. She stayed in bed and drank lots of fluids and toughed it out. By New Year's Day (reported as 30Dec2020) her fever broke but she was so weak and didn't work. She was back at work now. Also, she experienced site soreness from the injection since 19Dec2020. She did have a cough or any shortness of breath. She felt awful. She had recovered. She was just a little nervous because everything she read said the reaction was more severe with second injection. She planned on getting the second shot. She would have a repeat Covid test on 07Jan2020. Reporter seriousness for fever 103: Medically significant. Reporter seriousness for severe aches: Medically significant. Reporter considered the causality of the event site soreness was related with bnt162b2, of the events fever 103 and severe aches was unknown. The outcome of the event fever was recovered on 30Dec2020, of event ache was recovered on 31Dec2020, of event chills was recovering, of event vaccination site pain was recovered on an unspecified date in Dec2020, of events cough and shortness of breath was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever, pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Approximately 20 minutes after vaccine administration, patient reported feeling swelling of throat and tonsils. Patient did sip water and was verbally communicative and was texting on phone with pale, anxious appearance with not obvious shortness of breath noted. 911 was called to Center per vaccine clinic protocol at which ems initiated IV and took patient to ED.

Nausea; Diarrhea; Jitteriness; foggy head or brain; she can't concentrate /she didn't pay it any attention; sleeping a lot; sick; Headache; body aches; This is a spontaneous report from a contactable nurse. A 62-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 05Jan2021 08:15 at single dose for COVID-19 immunisation. Anatomical location of administration of vaccine was right deltoid. Medical history was not reported. The patient previously took omeprazole (PRILOSEC) and experienced drug hypersensitivity and lip swelling. Concomitant medication included atorvastatin (LIPITOR). The patient experienced headache on Jan2021, body aches on Jan2021, nausea on 06Jan2021, diarrhea on Jan2021, jitteriness on Jan2021, foggy head or brain on Jan2021, sleeping a lot on Jan2021, sick on Jan2021, she can't concentrate /she didn't pay it any attention on Jan2021. The outcome of headache and she can't concentrate /she didn't pay it any attention was recovering, of pain, jitteriness, foggy head or brain was not recovered, of sleeping a lot and sick was unknown. Nausea, and diarrhea recovered on 07Jan2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events headache, pain, nausea, diarrhea, feeling jittery, feeling abnormal, disturbance in attention and hypersomnia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was really scared; Excruciating pain on left ear; swelling in arm; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: ES1685, Expiry date: 01Mar2021) via intramuscular (left deltoid) on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She stated she is very healthy and don't have any medical conditions. She further stated that it was a scary moment, she don't want to take any chances, she was really frightened (28Dec2020). She made a complaint to let know her experience with the vaccine. Her cousin took the vaccine and told her she needed to report these events. The patient stated she experienced side effects after the first dose of the vaccine: Excruciating pain on left ear, locked jaw, her left upper arm was hurting on 28Dec2020. The pain went in her jaws and she was unable to open her mouth on 28Dec2020. She took 2 Benadryl and it relieved her. She saw on television if you experienced any side effects to take Benadryl. She also took Tylenol for the pain. She also had swelling in arm on an unspecified date in Dec2020. She also experienced some memory loss described as short-term memory loss on 30Dec2020. She stayed in bed after the vaccine, she was really scared, and stated she had memory loss and she don't have any memory problems. She was unable to remember if her car was black. She was looking for a white car. She drives a black car. She stayed in bed all day on Tuesday. Patient was asking what will happen if she does not take the second vaccine. The same morning while she was waiting to get the vaccine, a co-worker sent her a video of a woman who had received a COVID vaccine. She does not know which one. The woman experienced Bell's Palsy. The woman was crying and her face was turning side ways. She stated some people were talking negatively about the vaccine. She stated doesn't want her face to be deformed. She stated what are the cons of not taking the second vaccine. Reporter assessed the events as non-serious. Outcome of the events some memory loss and locked jaw/unable to open mouth was recovered on 30Dec2020, outcome of the events excruciating pain on her left ear, pain went in her jaws, her arm was hurt was recovering. Outcome of swelling in arm and she was really scared was unknown.

20 mins later numbness in face a head. Blood vessel popped in right eye. Dizziness feeling out of sorts. Feels like flu shot.

approximately 2 hours after my vaccination, I started with a very severe headache and felt extremely tired. I had difficulty staying awake. I slept about 2 hours. When I woke up my headache was gone and I was no longer tired. I went to bed and slept well until a headache woke me up the next morning however it was not as severe as the previous night. I was a bit lethargic but not too bad. My headache continued until the evening of 1.11.21 however I was not lethargic and was able to work. Today is 11.12.21 and I feel fine. I had no injection site discomfort to speak of.

was afraid; she was nervous; vomiting; Fatigue; felt chills/chill became a bone chill, and she was freezing; felt chills/chill became a bone chill, and she was freezing; randomly felt miserable/she felt like her body was purging/feeling "blah"; she wasn't really eating; Feeling sick; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730), via an unspecified route of administration in her right upper arm on 22Dec2020 16:00 at single dose for COVID-19 immunization. Vaccination Facility Type is hospital and which was not a facility. Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing and it was maybe 10 years ago that she was diagnosed, and she was treated for her diabetes. There were no concomitant medications. There was no history of all previous immunization with the Pfizer vaccine (within 4 weeks) or additional vaccines administered on Same Date of the Pfizer Suspect. The patient received the first dose of the COVID-19 vaccine 22Dec2020 and is due for her second dose this upcoming Tuesday, 12Jan2021. She asked if it would be safe to receive the second dose at a different time, due to personal plans. She said after she received the first dose of the COVID-19 Vaccine on 22Dec2020, she was feeling sick in Dec2020. She said she had vomiting, chills, and randomly felt miserable, fatigue from 23Dec2020. She said she was nervous about getting the second dose of the COVID-19 Vaccine on Tuesday, 12Jan2021. She said she had plans around that time period and she was afraid she was going to be sick after she receives the second COVID-19 Vaccine dose. She asked if the second COVID-19 Vaccine dose had to be administered in the timeframe that was scheduled. The patient reported she felt chilled when she woke up the next morning, 23Dec2020. She said at first she thought she felt chilled because it was cold outside. She said after she arrived at work on 23Dec2020, the chill became a bone chill, and she was freezing. She said she realized the chill was not a normal cold feeling. She said by mid-morning on 23Dec2020, she began to vomit, and went home and went to bed. She said she got sick 2 more times that day. She said she went to work on Thursday, 24Dec2020, and randomly got sick. She said she wasn't really eating at that point (Dec2020), so it was not like she got sick before or after she ate something. She said she continued to get randomly sick through holiday, 25Dec2020. She said she felt like her body was purging. She said she was feeling "blah", but she was not bedridden or out of commission. She said she had no fever that she knew of. She said her symptoms resolved right after holiday, clarifying she started to feel like herself, saying she felt good. The patient declined any treatment and reported she didn't think her symptoms were that severe, though her family wanted her to go to the doctor. There was nothing had changed in her routine prior to receiving the first dose of the COVID-19 Vaccine. Reported she had blood work every 4 months, and her last blood work was probably done in Oct2020 or Nov2020. The events did not require a visit to emergency room or physician office. The outcome of the event feeling sick, she wasn't really eating, were resolved in Dec2020, outcome of fatigue, felt chills/chill became a bone chill, and she was freezing were resolved on 23Dec2020, outcome of vomiting, randomly felt miserable/she felt like her body was purging/feeling "blah" were resolved on 25Dec2020, outcome of fear and nervous were unknown.

Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. Within minutes her tongue was tingling with sensation of feeling full-felt funny. 30 min later had frontal/jaw headache. 60 min later chills with goose bumps all over while working (works as resp technician at NMCP). While walking to car, her upper arm and front of thighs hurt as if exercised too much. Self treated with Advil and tylenol. --- Next day 1/12 0100am awoke with severe bilateral shoulder joint pain extending to shoulder blades, stabbing abdominal/stomach pain, nausea, urge to vomit. she returned to sleep but awoke 6am with nausea and severe diarrhea and fatigue. She c/o nasal congetion, sinus fullness and severe post nasal drip x 24 hours. S/s persisted and left work early now with severe bilateral ankle pain. She was off Wed/Thursday. Wed 1/13 her shoulder pains eased but now with severe back pain. Wed evening noted tongue swelling sensation again (has pictures) and took oral benadryl and ice chips. She went to sleep. Thursday 1/14 bilateral knee pain/joint with increased nausea again - treated with zofran. Friday 1/15 returned to work, pain in knees made gait wobbly = treated with advil. Notified ID MD and director on tongue swelling and constantly trying to clear throat = sent to ER where treated with oral decadron and M Toradol for pain. She was sent home with prednisone dose pack and compazine. Recommended f/u with HCP for further testing to r/o possibility of a mast cell disorder of familial hypertrytassemia due to her history of multiple allergies/insect allergies--

On the evening of the vaccine day, recipient woke up with Fever, Chills, Body aches, and Fatigue. Called off of work.

Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = 102.4 F. Had to leave work. Slept for 18 hours, Symptoms continued for 48 hours.

Patient experience heart palpitations and was experiencing anxiety before and during vaccination. After sitting for 30 minutes after getting the vaccine patient felt more calm.

Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob. Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.

Felt itchy and shaky after vaccine. Left after 30 min. She later developed hives and was seen at ED. Per ED notes, approx 1 hour after vaccine, she developed mild erythematous rash over upper chest/ collarbone region. Slightly itchy. She took benadryl PO x 1 with resolution of itching and rash within 1-2 hours. Patient has noted she is needing to clear her throat more often, feeling like it is "a little mucousy". She does not have a frank cough. She denies SOB, chest pain, difficulty breathing, stridor, wheezing or nasal congestion. She does not feel her mouth, lips, face or tongue are swollen. She has no difficulty swallowing. She denies abdominal pain, vomiting, and diarrhea. Denies myalgias, headaches, chills or fevers at this time. Discussed can use additional antihistamine as needed for further rash. Does not need epi IM at this time. Reviewed common side effects for 2nd vaccine to expect in next 24 hours. Reviewed elevated BP and asked to recheck at PCP or next medical visit to monitor for possible hypertension

Extreme fatigue-unable to function-head congestion lasted approximately 48 hours slept approximately 36 of those hours

A little over 12 hours after receiving my 2nd dose at 8:42 am, I woke up at approximately 11:15 pm to find that my tongue and throat were swelling. I immediately took 1 25mg benadryl and went to the Emergency Room (ER). After many questions and examination of my mouth. I was given another benadryl, prednisone, and famotidine. I waited and was observed for approximately 2.5 hours in the ER. At that time it was obvious that the medication was effective and I was comfortable leaving the ER to return home. I had prescriptions for more prednisone and famotidine to take for 5 days. On Wednesday, I felt well enough to go to work at my school, though I did light duty. On Thursday, I was also at school and also attended a physical therapy session and exercise class. I talked at length with my PT about my experience and she could tell that I was feeling good (presumably from the prednisone) and cautioned me about not overdoing things during exercise. I felt like my tongue was beginning to swell and the PT mentioned that my words sounded a bit funny (she was the only one to comment on this). I then went to dinner at my daughters house and began to feel tired from the benadryl. Upon arriving home and getting ready for bed, my husband and I both noticed how flushed my chest and face had become during the day. My throat and tongue were still somewhat swollen and my throat was beginning to hurt. During the day on Thursday, I had registered with the local Covid information website and had received an email stating that I should feel free to call the triage phone number if I needed. At approximately 9:45 pm I called and talked with a nurse who urged me to return to the ER because of the flushing and continued swelling. In the ER I was seen by a different doctor who was concerned not so much about the swelling, but about the white streaks in my throat and had me swabbed for strep throat. That test was negative. He said he had read my chart from Tuesday night and felt that the medication that had been prescribed was appropriate and that he didn't feel anything needed to be changed. He asked about how bad my throat felt and wrote a prescription for Magic Mouthwash and I asked for an EpiPen, which he also prescribed. We arrived home at approximately 12:00 am, but it was still difficult to lie down and sleep. I had already decided that I would not go to school on Friday and stay home and rest. I needed to pick up my prescriptions when the pharmacy opened and I ran a few other errands while I was out, but returned home and slept most of the afternoon. I have not been very energetic this evening, but decided that I wanted to get this form filled out. At approximately 10:00 PM on Friday evening, I hope that I am able to sleep better than I have the last several nights.

Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; Swelling; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: Ek5730, expiry date not reported) in the right arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 08Jan2021 at 18:00, the patient experienced brain fog, headache, muscle spasm at injection site, severe fatigue, joint pain, driving difficult and swelling. It was unknown if treatment was received for the adverse events. Clinical outcome of the events was not recovered.

joint pain; bad back spasms in the middle of the back radiating up through right should to right arm; Sweating; arm pain; she couldn't do anything with her right hand. She "couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing".; arm shoulder blade rib cage are sore; arm shoulder blade rib cage are sore; This is a spontaneous report from a contactable consumer (patient, healthcare tech in the ER). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Jan2021 at single dose for COVID-19 immunization. Medical history included spondylosis. Concomitant medications were not reported. patient calls today to report symptoms following administration of the covid vaccine. Caller reports that she got the vaccine on Friday. Reports that on Saturday she started to have joint pain everywhere on Sunday she felt a little better. Reports that on Monday she got up and had really bad back spasms in the middle of the back radiating up through right should to right arm. She went to work, only worked for 2 hours and then checked into the ED. They did an EKG because she was sweating and was with arm pain. They did X-rays and gave her steroids and gave her a pain shot stating it didn't do anything, states they put her on steroids to come home with, muscle relaxers to stop spams. Reports that on Monday night she couldn't do anything with her right hand. She couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing. The spasms won't stop, everything; arm shoulder blade rib cage was sore. Went back to the ER on Tuesday, they did a thoracic and cervical MRI, nothing looked different or wrong. they told her to stay on steroids and keep taking muscle relaxers, with ibuprofen and Tylenol. She also asks, what should her do, and if her history of spondylosis triggering this reaction. Patient was recovering from joint pain, was not recovered from bad back spasms in the middle of the back radiating up through right should to right arm and arm shoulder blade rib cage are sore. Outcome of the events was unknown. Identification of the case safety report serious was No. Information on the Lot/Batch number has been requested.

Patient reported on 1-27-21 at 11:40am to Employee Health office that on 1-8-21 3:15pm received COVID dose #1 at staff COVID vaccination clinic - waited 15 minute observation then returned to workstation. About 20 minutes after vaccination began experiencing light headedness, anxiousness, agitation and heart racing. Symptoms increased over next 1-2 days then diminished over the following week. Did not report symptoms. Stated "feeling like myself now"

migraines; arm is sore where the injection; she could hear like blood going through her, and if she moved it got faster and faster; Chills; muscle aches; not feeling well; Headache; fever; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 21Dec2020 by injection once to right arm (Lot Number: EJ1685) at SINGLE DOSE, via an unspecified route of administration on 11Jan2021 (Lot Number: EL3302) at SINGLE DOSE for covid-19 immunization (reported as healthcare worker, medical receptionist). Medical history included Other Conditions No. There were no concomitant medications. The patient experienced fever on 11Jan2021, headache on 12Jan2021, chills on 12Jan2021 23:30 , muscle aches on 12Jan2021 06:00, not feeling well on 12Jan2021 , migraines and arm is sore where the injection on an unspecified date. The caller had her second vaccine (later clarified as COVID vaccine) on 11Jan2021, and had the same symptoms as on the first one. They were not as bad, and she thought the first one was pretty bad. She previously reported her symptoms with the first vaccine. Symptoms with the second were fever, headache, chills, of course, and muscle aches, her arm weighs a ton, and not feeling well. Fever was noted when she was sleeping, it is now 99.6, but it was was 103. Headache was noted in the early morning, it was not a normal headache, it was the worst thing, and she is prone to migraines, but this was not even like that, she could hear like blood going through her, and if she moved it got faster and faster, one time, she stood still and it was like ahhh! Chills started about 11:30 last night, they went away this morning, about 11AM. Muscle aches started at 6AM yesterday, and are finally gone, as of probably about 9AM, they are fine now, just her arm is sore where the injection was. Not feeling well started yesterday and is getting better. First dose was 21Dec2020, she previously provided lot EJ1685, confirms both were Pfizer vaccines. The outcome of the event fever, not feeling well was recovering, headache recovered on 13Jan2021, chills recovered on 13Jan2021 11:00, muscle aches recovered on 13Jan2021 09:00. No follow-up attempts possible. No further information expected.

Felt woozy like; felt like she's drunk. Pt denies tightness in chest, jaw pain or heaviness in chest. Treatment: Rest and water also referred to primary care clinic as she refused to go to the emergency room for further care. The pt was able to walk without assistance and stated she was fine.

(Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point pupils, unable to talk, headache, facial and lip numbness, numbness traveled down the right side of my body (side of injection) trembles, weak legs, very weak all over. EMTs were called but I didn't go to the hospital. My son picked me up and took me home because I was unable to drive. On the way I experienced loss of vision and speech for about 5 minutes. When I got home, my legs were so shaky that I had to have help walking. I started getting severe chills that took 3 hours to get warm (2 heavy blankets, space heater, and heating pad). I was very fatigued and felt bad the rest of the day. (Saturday)The next day I had flu-like symptoms; headache, joint aches, chills, nausea, extreme fatigue. Sunday was better but still had to rest most of the day because when I would stay up for over 30 minutes, the symptoms would return. Monday- stomach cramps, headache, fatigue but went to work (30 minutes late due to stomach) and left 30 minutes early.

On the day following the vaccination, I had fever 100.3 and when I took a nap in the afternoon I had nightmares and had difficulty waking up. It felt as though I had been drugged.

Second vaccine given on 1/28/21. Got sick later that evening with pain & soreness at the injection site. Along with a severe headache, nausea, and chills. The symptoms lingered over the next couple of days. Contacted Employee Heath and manger the following day. Stayed out of work on 1/29/21.

chills day 1 and 2; tiredness; headache; muscle pain; joint pain; feeling unwell; dizziness; weakness; sleeplessness; sinus unable to drain, feels like sinus infection but no fever; This is a spontaneous report from a contactable health care professional (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283) in the hospital, via intramuscular route of adminsitration on 08Jan2021 at 15:00 at a single dose on the left arm for COVID-19 immunization. Medical history included Diabetes, High blood pressure, Osteoporosis, Hyperlipidemia, GERD, Diverticulosis and allergies to soaps, shampoos and lotions all from an unknown date and unknown if ongoing. Concomitant medication included metformin (manufacturer unknown), losartan (manufacturer unknown), ezetimibe (manufacturer unknown), esomeprazole (manufacturer unknown), dulaglutide (TRULICITY) , hctz (manufacturer unknown), denosumab (PROLIA), Alive multi vitamin (as reported), vitamin d3 (manufacturer unknown), ascorbic acid, colecalciferol, copper gluconate, cyanocobalamin, durapatite, folic acid, glucosamine hydrochloride, magnesium oxide, manganese sulfate, phytomenadione, sodium borate decahydrate, zinc amino acid chelate (BONE UP), alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) and curcuma longa rhizome (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]). The patient had no other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination. It was reported that the patient had chills day 1 and 2, tiredness, headache, muscle pain, joint pain, feeling unwell, dizziness, weakness, sleeplessness and sinus unable to drain, feels like sinus infection but no fever all on 08Jan2021 at 19:00. The patient took Advil, Mucinex and Walphed as treatment for the events. The outcome of the events was not recovered. The patient has not been tested for COVID-19 post vaccination.

My blood pressure shoots up really high; My upper body got red like tomato; I was really like confused for several hours; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration at left shoulder on an unspecified date at single dose for COVID-19 immunization. The patient medical history included food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient reported that: "my reaction was my blood pressure shoots up really high and my upper body got red like tomato and I was really like confused and 'spacing' for several hours". The patient did not receive any treatment. The patient outcome of the events was unknown.

Started to have weird body weakness sensation associated with mild nausea when I lay down at night. Almost every night. As soon as I lay flat. Comes in waves. Causing me having problems falling asleep. Also happens when I tried to fall back to sleep. Mostly when I am about to fall asleep. During the day I am ok if I am upright. No fever or other symptoms. Getting insomnia from it every night.

I had difficulty forming thoughts and speaking in more than a few words at a time. I was aware I was trying to think or respond, but felt somehow blocked from access and ability to think and speak. This experience lasted for about 28 hours, and then my access to cognition returned. By the way, I am a doctoral level psychologist for whom these skills are typically easy.

On 1/8/2021 2 days after I received the Covid vaccine I started to have SOB and coughing. I started to used my inhalers and it would give some relief but I was using it more than normal. I had not had asthma attack for more than a year. My asthma is very controlled that I don't use any inhalers whether daily or as needed. I went to work as usual since at that time my symptoms weren't getting worse but also not getting better. On 1/19/21, I was feeling more out of breath and having more dry hacking cough that when I called EH I was told to do the Covid testing. That same day I called my Asthma doctor and did a video call and was prescribed Breo inhaler, spiriva inhaler, xoponex nebulizer treatment and xoponex rescue inhaler. I couldn't go to work because of my shortness of breath and coughing. The treatment didn't work. On Tuesday 1/26/21, I called my asthma doctor again and another video call was made. She changed my inhaler to symbicort, still continue spirirva inhaler and nebulizer treatment. I also contacted my primary doctor who asked that I schedule an appointment with him so he can see me. On 1/28/21, I saw my primary doctor who did blood works to see if I have any blood clot and to see how my heart was doing. I was given phenergan with codeine to help with my coughing and it did help me to go to sleep. My blood works came out negative and he ordered CAT scan of my chest since I can't get rid of my SOB and coughing. I had the CAT scan on 2/3/21. He called me the next day and I was told that I had mucous plugging. He told me to go home and he prescribed Duoneb nebulizer treatment 4x a day and spiriva inhalers 2x a day. I started to get rid of the mucous that I had and started to breath better. It took 4 days of 4x a day nebulizer treatment and inhalers before I started to feel

woke up not feeling good; a few hours later headache and dizzy; dizziness increased; driving and hard to keep eyes open; feeling overall sick and getting very hot; threw up quickly three times water only nothing in my stomach. Got home and went to bed and slept for a few hours. Woke up and felt better. Headache and fatique so rested the day; next day felt better with headache and rested. Third-day slight headache but felt much better.

collapse and passed out; Woke up at midnight with severe leg cramps; I turned white as a ghost and sweats; I turned white as a ghost and sweats; Got the chills after sweating; This is a spontaneous report from a contactable 62-year-old female consumer reported for herself that she received 1st dose of bnt162b2 (BNT162B2; lot number EL9261) on 26Jan2021 04:30 PM at left arm for COVID-19 immunization in Public Health Clinic. Medical history and concomitant drugs was none. The patient woke up at midnight with severe leg cramps, tried walking it out, collapse and passed out (according to husband). He stated that the patient turned white as a ghost and sweats. After coming too, drank electrolytes and water. The patient got the chills after sweating. It took a while for her to warm up and go back to sleep. Event start time was reported as 27Jan2021. The outcome of the event was resolved.

The day of the shot, I was fine. But I went to bed at about 10:00 that night and slept very little. I was chilling so badly that I couldn't get to sleep! When I got out of bed in the morning, I could barely move due to severe muscle pain. I did very little all day, suffering from what felt like the flu: chills, loss of appetite, and "brain fog" such that I couldn't read or think clearly. My head felt warm, but I never took my temperature. The next morning, I noticed hives on my chest between my breasts and around the armpit of my left arm. The following morning, now about 45 hours after my second injection, I still had pink hives, and my left armpit was swollen so that it wasn't concave, as it always is, but convex. Touching my armpit hurt, and I think some gland in it was swollen. Similarly, a gland on the left side of my neck was swollen and painful to the touch. Today, now the fourth day since the injection, the hives have subsided, and my glands are almost back to normal. Overall, I am very glad to have had the opportunity to get the vaccine, but I haven't felt that sick in years.

01/07/2021 Started having low back pain on right low back took Advil on the 01/08/2021 horrible pain the radiates around pelvic area and across the whole lower back, called off work and went it to Physician in the afternoon. Examined for Muscular Cellular was prescribe Flexeril 10mg once a day at bedtime, Naproxen 500mg twice a day. Took them about three days was able to go back to work.

Swollen lt. arm, severe body aches and pain, headache, excessive sweating for 14 hrs. Missed work on 1/27/2021. 8 hrs.

Patient came to site for scheduled appointment to receive 2nd dose of Pfizer Covid. States she would like to reschedule because she was not feeling well. Reports she has not felt well since the first dose. States initially she felt dizzy and had a headache - the symptoms progressed to dizziness, headache unable to be relieved by medication, stomach pain and nausea. States she has consulted with PCP and lab tests will be ordered, she anticipates she will receive an order for a MRI of the brain. She also stated because of her symptoms she was considered by her work as a presumptive positive for Covid and was required to complete three Covid tests - all were negative. Encouraged patient to continue consulting with PCP and possibly an allergist. She will reschedule when she is feeling better.

The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperature; Difficulty remembering things; Vomiting; Headache 10/10; developed a red area below injection site/The site got worse through Thursday and was red, hot; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in right deltoid on 24Jan2021 at a single dose for prevention (COVID-19 immunization). Medical history included Low immunoglobulin/compromised immune status/Low immunoglobulin diagnosed 8 years ago, hereditary angioedema from 2010, asthma diagnosed in her 20's, Allergic to Thermarisol, diagnosed allergies, respiratory illness, and endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (LOT number: EJ1686) in right deltoid on 03Jan2021 for covid-19 immunization, and flu shot on Sep2020 without adverse event. She got second injection on 24Jan2021. On 25Jan2021, she woke up with 100.5 degrees temperature and could not stop vomiting. She had to go to the ER. They gave her Zofran, IV and also Toradol because she had a number 10 headache. She continued with low grade temperature throughout week from 99.5-100.5 degrees Fahrenheit, and by Tuesday morning, she developed a red area below injection site. By Thursday, there was a red area growth to 13 cm x 15.5 cm on the injection site. She could not remember her email address and said her brain was not thinking. This started after the vaccine that she began having difficulty remember things. She never had a headache that bad. It improved but she has a lingering headache still. She continued to have a temperature from Monday to Saturday. Currently, she does not have an elevated temperature. Difficulty remembering things was reported as just irritating, but significant. The site got worse through Thursday and was red, hot and ended up measuring 13 cm x 15.5 cm. Regarding weakness, she could walk but medics had to help support from her seat to the ambulance. The outcome of the events red and hot injection site was not recovered; the outcome of the events vomiting, headache, weakness was recovering. The outcome of difficulty remembering things was unknown. The outcome of high temperature was recovered on an unknown date. The events was assessed as medically significant.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and the use of BNT162B2 cannot be excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.

About hrs after receiving injection- bad headache started - same as with the first injection. Not debilitating. Then extreme fatigue started, some minor dizziness. Not debilitating. I work in a cardiology office. Administrator advised me not to come in. Ended up sleeping for most of the next 18 hrs. No nausea, no elevated temp. Just unbelievable fatigue.

01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Called dr and had a Telemed call with NP on Tues. 01/26. Predisone and Benadryl was prescribed. Thurs. 01/28 Call to let them know that it wasn?t working. I went into the office for one shot of Solumedrol. This help and they were gone. They gave me second dose of Predisone to take in case it came back and to continue the Benadryl. 02/8 Second vaccine. Hives began that night: arms, torso, thighs, hair. Call the Dr. on 02/10 and suggested I go to an allergist. Went to allergist on 02/11 she said to only take one Predisone, Allegra one am and one at noon, then take zertek at nighttime. The Predisone created a major brain fog, I had to stop. Saw the allergist on 2/18, she agreed to get off the Predisone. 02/11 I passed out in the am and when I woke up with vomit running down my face. Still suffering with hives this entire time. 02/17 my face, lips, tongue started to swell and I had chest pain for 90 minutes. My feel swelled and I have hives so bad on my feet I could not walk or put on shoes. 02/20 Woke up with sweat on my chest. My hands were so swollen I had to have my wedding ring was cut off . 02/21 I went to the Urgent Care and received a shot of Solumedrol. They said this should last me for a few days. 02/21 woke up 3 time throughout the night soaked in sweat.

2/3/21: c/o Fever, headache and vomiting; 2/3/21 at 7am: Fever escalated; 2/4/21: Temp: 104; admitted to hospital; Dx: HSV-1, Encephalitis; Tx: Acyclovir IV TID x 3 weeks, completes tx on 2/25/21 Admitted total of 6 days 2/10/21: discharged home, continues to have difficulty with computation of numbers and naming objects

Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoarseness, severe fatigue, headache, brain fog for first 20 hrs, then intermittent eyelid and face swelling, hoarseness, fatigue and brain fog for the next 3 days, followed by mast cell activation symptoms of fatigue, puritis, and mild racing heart in the evening for the last two days. For the past 3 years I have been medication free and virtually symptom free. The symptoms of the last few days are consistent with those I had during the years when my MCAD was active. I am concerned that the vaccine has reactivated the hyper-sensitivity of my mast cells.

nightmares; difficulty waking up; This is a spontaneous report from a contactable pharmacist (patient). A 62-year-old non-pregnant female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8292), via an unspecified route of administration in the right arm on 27Jan2021 07:15 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) on 09Jan2021 04:45 PM in the left arm for covid-19 immunisation. The patient experienced nightmares and difficulty waking up on 28Jan2021 14:00 with outcome of recovered in 2021. This was very unusual for patient. Events assessed as non-serious. No treatment was received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications that patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.

mild headache at waking up and during the day on and off sweats on and off chills on and off feeling unwell as if I will get a flu or heavy cold

PT reported feeling dizziness, anxiety, and BP was 130/106 when reporting she did not he a hx of elevated blood pressure. Pt reported not eating anything all day except for two oranges. Pt reported feeling the room was "spinning". Pt given snack of granola bar, then rice crispies, and finished a juice box and a small water bottle. Pt was able to ambulate unassisted to bathroom at 1545. Pt called her husband to pick her up, and pt left with husband at 1555. Pt denied symptoms at that time.

Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm couldnt sleep ..suicidal thoughts/OCD negative thoughts,very depressed... got up at 6pm. Next day woke up with headache started to clean tired and depressed. Dizzy and tripping over my feet. Next day woke up with headache started to clean got very tense and lightheaded and weak. Had to sit. Husband took blood pressure and it was 70/50. took again diff arm same. Sat for 1/2 hr went to 100/74. Feeling weak all day. Very confused no memory. Went to bed took Seroquel to calm down and sleep. Add note: I have been depressed for a while but the drop in blood pressure, drop in mood(bad) and weakness and dizziness happened after shot. Im afraid to take the 2nd one because of how it affected my mood. and blood pressure.

I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day 10 after the vaccine and my mast cell reactivity symptoms have increased by the day--internal and external swelling, flushing, pruritis, wheezing, tightness in chest, as well as pain and pressure in arm pits, groin, and ears. By late afternoon I am severely fatigued, weak, and foggy-headed. These symptoms are consistent with those I experienced during the twenty years when my mast cell disease was unstable. Through identification of my triggers and avoidance of the same, I have been symptom and medication free for the past three years--until taking the Covid-19 vaccine. It appears that the vaccine has reactivated an excessive degranulation response in my mast cells and that response is getting worse as my body responds to the vaccine. I realize that the percentage of persons who suffer from a condition like mine is small, but I would have appreciated having the information that I am submitting to you when I was weighing the pros and cons of vaccination. I know from the twenty years of navigating this disease that there is nothing that can be done at this point other than taking various H1 and H2 blockers. This vaccine appears to be undoing the hard-won level of stability achieved through years of careful lifestyle management.

Pt felt light headed, had Elevated BP 177/1106, HR 86, Pulse Ox 98% on room air, very anxious, placed on cot, feet up, with OS symptoms improved as did blood pressure

15-20 after vaccine was administered I felt very confused and couldn't remember where I put my card, my pocketbook, felt pretty disoriented. I remember someone telling me to sit down and eat something. (I had already had lunch and a snack). That evening I started to have a bad headache. Thursday morning I had a very difficult time getting up and was extremely fatigued; felt hot. I felt exhausted all day and looked pretty tired and pale. Friday morning still tired, had some bouts of energy, but they didn't last long. Body aches were worse and I also had some stomach discomfort Saturday felt like I had a sore throat, felt weak, and still pretty tired. I had some problems catching my breath when climbing stair and and at one point felt hot and clammy. Headache was better.

Seven minutes after receiving the Pfizer Covid 19 vaccine the patient reported having the feeling of being high lasting 10 minutes, elevated heart rate, dizziness and weakness for 1-2 minutes length, blurred vision and "brain fog" lasting for about 24 hours

Patient received vaccination at pharmacy and then went to office in back of store to work. received call from back about 1 hour later stated patient was feeling unusual. Went to back of store and checked patient. Patients blood pressure was elevated at 180/100. Patient temperature was normal. Discussed with patient and she decided that she would like to go to clinic to be checked

Dramatic flu symptoms. Extreme chills freezing cold extremities, fever, aches insomnia nose discharge, loose stools, headache, light nausea but did not vomit. Still not feeling well. Symptoms have decreased and can now sit in a chair as apposed to lying in bed.

Approximately 39 hours after immunization I woke with abdominal cramping. Upon standing I became light- headed and fell. My legs and arms turned red and warm and started itching. Itching subsided in an hour but redness remained for several hours. After itching stopped chills started and lasted several hours . By 7am symptoms were gone except for redness.

Exactly 12 hrs after second injection I had 103 temperature, severe shakes and chills. Both knees and arms at the elbows swelled and the elbow and Lymph nodes on my right inner elbow are still swollen. I am just now able to grip anything with my Left hand. I had both vaccines in my right arm. I am predominantly left handed. This has affected my work asin which I am still working full time.

After receiving my first Pfizer vaccine on 2.24.21 at 4:45 p.m., I felt well. I woke the next morning 2/25/21, and felt fatigue, arm was tender but not sore. Earlier that morning, I had an aura, but no migraine materialized. Around 10 a.m., I began to have chills, more fatigued, and sore muscles. Left work at 3 p.m. Arrived home, went to bed with temperature of 101.2. Took Tylenol. Friday, Fever was gone, felt fatigued, arm still tender, and had a headache. Took Tylenol. Did not go to work on 2/26/21. Saturday, 2/27/21, woke at 4 a.m., right arm where vaccinated was very sore, armpit very sore, and right breast very sore. Placed cool compresses on my breast, arm pit and arm where vaccine was given. Took Tylenol. Still fatigues, achy, with sore shoulder muscles. Sunday, 2/28/21, Vaccine arm still sore, with some soreness still in right breast area. Took Tylenol. 3/1/21, called Dr. Still a bit achy and arm still tender

The night of the injection, I had severe pain in my neck, back of my head and right arm. The pain was so severe that I could not move my head or arm all night. I took Advil but could not sleep from the pain. When I did manage to sleep, I would have horrible dreams. By morning, I was feeling better but still sore from my neck and arm. I felt very tired and rested the entire next day. Pain has not returned. It was very scary.

Confusion, Headache, Sedation, Myalgia, Arthralgia & Fever Narrative: Employee c/o H.A., muscle,bone pain and aches, fever, chills, loss of energy, foggy brain.

Patient developed typical viral type symptoms ( felt foggy and "off") Saturday evening and woke overnight into Sunday with severe itching which lasted all day Sunday despite Benadryl and Pepcid and lotion. I saw patient Monday morning and she had hives on back, abdomen, arms, and some starting on legs. Given extent of hives, we administered IM steroid and prescribed Medrol Dosepak. No airway involvement. No prior history of reactions to vaccines. Will not know how effective steroids are as this is an urgent care, but she was feeling some improvement after sitting for 10 minutes after the steroid injection.

A couple of days after at 10:30 PM I had a fever of 101.5 with a headache in the front on top of my forehead. I stayed home from work the next day and my fever was 100.0. Tylenol helped. I felt tired but better. It became difficult to breath. It felt like I had chest pains especially on exertion. It improved if I sat down. It lasted aa week. My doctor sent me for a chest x-ray and blood tests. I had contracted Covid-19 on the third week after my first dose of the vaccine. Positive test results on 01/11/2021.

Serious swelling and tenderness in arm pit and side, upper back, lymph nodes in neck and back of skull. upper chest and back of neck with horrible headache, Fever of 101.4, chills but major sweating. Ear aches in both ears from headache. Stomach upset for 4 days and couldn't eat. Body aches. Sleeplessness. Very light headed couldn't think for 4 days.

she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed; the lymph node under her arm got inflamed; armpit swelling; her eyes was runny, sort of hurting like salt in her eye; her eyes was runny, sort of hurting like salt in her eye; arm was hurting where she got the vaccine in the right arm; she had a mucus plug and was bleeding; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 62-years, via an unspecified route of administration in right arm on 19Feb2021 at single dose for COVID-19 immunization. Medical history included hadn't had her period for 8 years. Concomitant medications were not reported. The patient historically received first single dose of BNT162B2 at the age of 62-years for COVID-19 immunization. Patient received the 2nd dose of the vaccine last Friday 19Feb2021, when she was driving home her eyes was runny, sort of hurting like salt in her eye, it was like that all evening she had to put a patch on her eye to help it. That same evening may arm was hurting where she got the vaccine in the right arm, and the lymph node under her arm got inflamed. The next morning on 20Feb2021 when she woke up she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed, but that went away. The armpit swelling has continued since the day of the vaccine. Now this morning in Feb2021 she had a mucus plug and was bleeding she haven't had her period for 8 years, every two days she had something new. Patient wanted to know what had been woken up in her body. Consumer added that she read on line that patients should wait for 5months before going to their doctor about the swollen lymph nodes because they might send the person for a test, mammogram and it may say they have cancer, in the clinical trials apparently some patients has issues with their lymph nodes and when they did testing it was found they had cancer, but it was not cancer it was the vaccine. Outcome of the event she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed was recovered/resolved in Feb2021; of the armpit swelling was not recovered/not resolved; while of remain was unknown. Information on lot/batch has been requested.

Difficulty breathing, fast heartbeat, tongue numbness, dizziness, edginess, chest heaviness starting within 1/2 hour. I am four days into symptoms. I still have some chest heaviness and still having asthma issues which includes coughing. I also had side effects of sore arm, chills, fatigue. Did not seek treatment. I had no idea how long this would last. I wish I would have read the paperwork for severe allergic reaction, but I didn't. I would have gone to the ER. I have suffered with this since Saturday.

I had arm pain, aches, tired and vomited a few time. I felt weird all over. I had pain in my upper abdomen, legs and lower back. Chills and anxiety. On 2/8, I had a tele visit with my doctor. I took Tylenol as instructed to make sure that I didn't develop a fever. My doctor said that it could be from the vaccine. My left leg and foot were swollen on 2/13, so I called my doctor again and he sent me for a Doppler to check for a blood clot. I saw him on 2/15 in person. I have lower back pain and weakness in my legs at times, but it doesn't prevent me from doing anything. They feel heavy, especially if I walk for an extended period of time.

My arm has remained sore since the shot 4 days ago. Specifically in the armpit but aches all the way down to my hand at time. My armpit is swollen and painful. The pain goes thru my underarm down to my hand. The pain makes it difficult to sleep. Tylenol doesn't take the pain away. At first I thought the pain was a side effect to the initial vaccine, but it got worse as time went on. Finally I researched it on line and saw that lymph nodes have been reported as swelling due to the vaccine.

Dizziness, feeling disconnected, off. Happened immediately. Felt better the next day but have had the same feeling since the 3rd day. This is day seven.

high fever x 2 days, low grade fever x 1 day, fatigue, body aches, severe chills, shaking, brain fog x 4 days , injection site reaction - swelling and redness in entire L arm x 3 days, hot flashes with intense sweating.

3/20/21: Sudden fatigue, body aches, malaise, sweating lasting throughout the day. 3/21/21 previous day's symptoms improved with some lingering fatigue but increasing manic symptoms, including perseveration, inability to focus, paranoia, manic anxiety, inability to make decisions, racing thoughts lasting throughout the day but clearing by the morning of 3/22/21. SYMPTOMS VERY SIMILAR TO ADVERSE REACTION TO CANNABIS

Waited 30 minutes. A little dizzy. Son drove me home. Arrived home 450. 5 pm eyes and cheeks swelling throat felt like olive stuck in it I called Kaiser. Talking to them chest began stinging hurting pressure. Told to call 911. I hung up walked two blocks to urgent care. Chest really hurting feeling dizzy face eyes swelling throat lump getting larger. My breathing rate normal , blood pressure normal , oxygen normal. They took me back gave me epinephrine and depo modral shot in right buttock cheek. After few minutes felt better chest stopped increasing in pain throat started feeling better, face still swollen. Told me good thing I walked instead of waiting for 911. Very scarey. Told to remain up for 24-48 hours give epi if needed again. Taking 180-360 mg 24 hr Allegra daily. I stayed up 36 hours drank water . Told can not take second shot. No vaccines until I get tested for what caused allergic reaction. Today March 23 face still off and on swelling and eyes. Seems when I begin to move around swelling starts again.

I have a complex history of anaphylactic reactions to many allergens. Immediate reaction to Pfizer vaccine #1--flushed/hot, strong metallic taste, chemical smell, tachycardia (156-158), nausea, some chest discomfort and dizziness. BP 158/85 (my normal is 100/60). O2 sats 98%. I did not feel anxious until heart rate would not come down to baseline. Clinic staff monitored me and did not treat. Allowed heart rate to decrease over time. Took over 20 minutes to get below 120. At 35 minutes, it was below 100. Stayed at clinic for one hour and released. Still had metallic taste (over 3 days now), loss taste, loss of appetite, headache, and fatigue.

3/25/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: Anxiety . Assessment : Time of assessment 1200. Alert and oriented. Actions taken: Bp- 139/83. P- 77, O2- 100% Medications administered: none Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/25/2021 11:45 AM 0.3 mL 12/11/2020 Intramuscular

I was VERY T i ???????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? ?? ?? ?? SORRY about the above I'm not sure what happen tried to delete it but couldn't! I woke up Sunday 14th at 7:30AM feeling really tired. had coffee & could barely stay awake. by 8:30AM I went back to bed woke up 11AM ish had lunch could hardly keep my eyes open went back to bed & slept the afternoon away. got up 5PM ish had coffee & supper still very tired I went back to bed. woke up around 10AM had something to drink & bathroom then went back to bed & slept to morning. On Monday the 15th. & Tuesday the 16th. was pretty much the same as the 14th. On the 17th. woke up at 8:45AM FEELING GREAT! No other problem but being very tired!

Ever so slight tingle in tongue within 30 mins with difficulty moving legs. Arrived home and slept 5 hours. Spouse woke me up to eat. I was polite and took a few bites. Went to bed @ 10 pm. The next morning I woke in the fetal position and COULD NOT MOVE! Called husband for help. He lifted me to the sit up position by my rib cage. Very difficult to move for 4 days. Had Gammagard treatment on March 16. 2021. That was a mistake, I guess. I could not even think clearly enough to try to fill out this form.

Severe chills/sweats, extreme fatigue, disrupted sleep, no appetite, shaky for 6 days but appear to be lessening now

Constant headache Body on fire Fatigue Nausea Dizziness Pain and muscle ache Anxiety High blood pressure

Once I?d gone to bed on 3/25 about 10:30 pm. I woke up later that night feeling uncomfortable and restless. Had cold chills and headache when I woke up the next day I was extremely tired and felt like I had flu like symptoms The following day(Saturday) I felt like normal again myself again

3/28/2021 (patient) was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: Hot, jittery. Assessment : Time of assessment 1332 Alert and oriented. And anxious Actions taken: VS taken at 1332, BP- 199/147, P- 123, O2- 100%,placed on stretcher, offered water and drinking, patient reports that she took her BP meds late today, VS recheck at 1344- BP- 182/73, P- 90, O2- 100%, symptoms residing, daughter in room. 1350 BP- 175/72. P- 89, O2- 100%, at 1400, BP- 174/89, P- 64, discharge with daughter at 1402. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/28/2021 1:27 PM 0.3 mL 12/11/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8733

1st dose I had soreness in left arm and a stomach nausea the next day. 2nd dose I had at 2:00 p.m. on 3/26/21. Woke up the next morning at 4:00 a.m. with pain in my arm and basically feeling terrible. I had pain in the arm, soreness under arm, achy and severe joint pain all over, headache over my eyes, extreme fatigue, chills on and off, a few instances of sweating, Generally felt really sick. Appetite decreased. The next night woke up in the middle of the night sweating, then later in the night with chills. Aching and pain in joints was miserable. By noon on 3/28/21 was feeling a lot better, still tired and arm just sore. Stomach still a little off.

Initial reaction was extreme exhaustion. Wake up after about 5 1/2 hours with migraine-like headache. I took 2 Advil, when normal dose is 1, for me. I have been taking an average of 3 Advil every day since the vaccine because of the pain from the headache. I would guess last time I had to take Tylenol or Advil for pain was about September or October, 2019.. Depression is beginning to take hold, likely because of the headache; it has become very hard to work and concentrate. External body temperature is measured most days and it is only running about 97.8-98 F. Before vaccine, usual temperature was about 97.3-97.7. (We have a body temperature scanner at work due to the pandemic.)

Woke up with severe vertigo. Could not walk, threw up several times in the course of six hours. Slept most of the afternoon, but was very nauseous could not stand up all day. In the evening started feeling slightly better and could walk to the bathroom unassisted.

After taking the vaccine, that evening my breathing worsened and I also had a gout flare-up. The gout pain was so intense even after taking two pain pills, it kept me up all night. I was unable to report to work the next day and had difficulty walking for the next 3-4 days and breathing for the next week. I was even getting up 2-3 times on some nights gasping to breathe.

After receiving the first shot, developed a headache on right side; later that evening had a runny nose; Nausea; Diarrhea; Loss of appetite; Sleep loss; Achy; Overall exhaustion; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6203, on 03Mar2021 11:00 at single dose in left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. After receiving the first shot, the patient developed a headache on right side on 03Mar2021 11:00, later that evening had a runny nose, nausea, diarrhea, loss of appetite, sleep loss, achy and overall exhaustion. This lasted for 7 days. Treatment received for headache and achy included Tylenol on day 3. The outcome of all events was resolving.

Fever of 101 that did not respond to tylenol. sever headache that did not respond to tylenol. fasting blood sugars went from 100 to 120. 1.5 hour post meal blood sugars went from 130 to 205. brain fog returned I had covid. Positive test was Nov 28, 2020. Last under doctor's care March 19, 2021 but that was a diabetes follow up.

I woke up at 5am the next morning feeling like my whole body was frozen. Every joint seemed stuck in place. It was bad everywhere, but worse on my left side -- shoulder, elbow, wrist, hands, and knee. Also my right hand. I took ibuprofen and went back to bed. I wasn't able to do anything. I was extremely tired. I took ibuprofen throughout the day to manage the pain and slept much of the day. I also was coughing quite a lot. Today I feel mostly back to normal. Very little pain or stiffness in my left shoulder, elbow and wrist. Less coughing too.

Foggy Head about 30 minutes post vaccine. Very dizzy and off center that night and the entire next day - about 24 hours. Was walking sideways at times Happening on and off since

Hyper feeling, talkative, then severe feeling of doom and depression a few hours after vaccination. She then developed worsened depression along with weakness and temporary hypotension with systolic BP to 50s.

I became itchy, especially in my face. My eyelids got swollen and my eyes were very sore. This continues today, the day after, although the eyelid swelling has gone down a little. My eyes look hooded. I was very restless at night due to the itchiness.

Severe depression episode occurring the first and second nights. First night I felt suicidal which is very unusual for me. Some accusing the following 3 days. Still waiting to see what happens moving forward but feeling much better.

On 2nd day after 2nd vaccine, I felt bad and began to have headaches. On about day 8, I began to have ear ringing along with headaches. It has been 36 days now. The headaches are still present but somedays not as severe. The ear ringing is 24/7 now and extremely annoying. Nothing I do will make it better.

Within 15-20 minutes, I had extreme fatigue and overall lethargic behavior for a very health 62 year old energetic woman. Brain Fog occurred and slowed speech. Could not lift my arms or stand and needed to be placed in a wheelchair. It took about an hour to start to feel more like myself and in 2-3 hours, I was able to walk out of the hospital emergency room by myself.

Within 3 hrs I started experiencing severe hip and leg pain. on left side. Excruciating pain during nighttime hours to the point you could not sleep. After 3 days it moved to knee. Went to emergency room at 3am April 4th. Discharged with no relief

Day 1 exhausted Day 2: Headache, sore throat, low fever Day 3: low fever abdominal pain on right side, Day 4: lightheaded /confusion

chills, extreme headache, dizziness, nausea, chest pain, racing heart beats, racing thoughts, can't sleep, left inner ear pain, blurred vision, pain in left elbow, numbness in left hand for 12 hours, shortness of breath, general weakness - adverse events have lasted over 48 hours - Advil taken with minimal reduction in symptoms

Patient is a 62-year-old, female. Alert, oriented X3, clear speech, able to answer to the questions before being vaccinated. At 3:34 pm, the patient received her first dose of Pfizer, (lot number EW0150, expires on 07/2021) on left deltoid, given by RN. The patient was able to give her verbal consent to receiving the Pfizer vaccine. RN, reports patient sounded "normal" and was responsive to all pre-vaccination questions. Patient reported mild anxiety to RN, immediately after being vaccinated. RN, followed the patient to the EMT observation area and assisted the patient to a zero-gravity chair. At 3:41 pm, while waiting in observation area, patient reported feeling "anxious" and "faint". EMT (Name), EMT (Name), EMT (Name) and RN, responded. At 3:41 pm, the patient became unresponsive to verbal stimulation. Her pupils were fixed and dilated. During this time, EMT took the patients vitals and found her BP to be 132/98 and HR 73 BPM. At 3:41 pm, RN called 9-1-1. The patient continued to be unresponsive for an additional 5 minutes with normal respirations of 17 per minute. At 3:45 pm, the patient jumped up out of the anti-gravity chair, screamed and proceeded to run down the hallway toward the patient restrooms. EMT followed the patient down the hall and RN followed. The patient collapsed to the floor and started to scream and convulse. While on the ground, EMT took the patient's blood pressure which was found to be 209/162 with a HR of 101 BPM. The patient was assisted to her feet by EMT (Name) and EMT (Name) and assisted her back to the anti-gravity chair at 3:47 pm. FD arrived on site at 3:48 pm and took over monitoring the patient's vital signs. The patient was A&Ox1 to self at 3:48 pm. She was unable to follow direction. Medical response assisted the patient to a stretcher chair with her arms and legs strapped to the chair. She left with EMS at 4:02 pm.

fever; feeling out of body experience; diarrhea; in tears from intensity of the sensation; visual pictures that were kind of ridiculous and seeing things; Severe headaches; Heard a lot of noises in head; body hurting severely where she couldn't walk; body hurting severely where she couldn't walk; no appetite; nauseas; This is a spontaneous report from a contactable healthcare professional (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6205) via an unspecified route of administration, administered in Arm Left, at the age of 62-year-old, on 18Mar2021, as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Oct2020. The patient's concomitant medications were not reported. The patient previously received flu shot as immunization and did not get any reactions and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6205) on 28Feb2021, single dose for covid-19 immunisation and experienced very achy, some fever, some diarrhea, one episode and a big headache, difficulty Sleeping, and intense sensations. The patient experienced severe side effects/ bad reactions three weeks after receiving the second dose of vaccine. The patient experienced visual pictures that were kind of ridiculous and seeing things (medically significant) on 19Mar2021 with outcome of recovered on 21Mar2021, severe headaches (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, heard a lot of noises in head (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, body hurting severely where she couldn't walk (non-serious) on 18Mar2021 with outcome of recovered on 21Mar2021, fever (non-serious) on an unspecified date with outcome of recovered on 21Mar2021, diarrhea (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, in tears from intensity of the sensation second half of the day after receiving Pfizer Covid Vaccine (non-serious) on 19Mar2021 with outcome of recovered on 21Mar2021, no appetite (non-serious) on 18Mar2021 with outcome of unknown, nauseas (non-serious) on 18Mar2021 with outcome of unknown, feeling out of body experience (non-serious) on an unspecified date with outcome of unknown. The diarrhea was reported as much more intense. The patient doesn't know how else to describe it, except it was very intense and severe. No appetite and nauseas which lasted 2-3 days, it's almost like feeling out of body experience. The events did not require a visit to Emergency room or Physician office. The patient did not receive vaccination within 4 weeks prior vaccination. No relevant tests performed.; Sender's Comments: Based on the close temporal relationship, the association between the event "seeing thingis" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

I thought that I had kidney stone; aches and pain/Pain in my right side was very severe/Body ache; Foggy brain; When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy; almost passed out; can't even focus; I was not feeling well; They did gave me Cyclobenzaprine, Prednisone and Hydrocodone and I took them for two days and then I just stopped because it was just making it worse and then I was foggy and couldn't event get up; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot Number: EN6206) as SINGLE DOSE for COVID-19 immunisation; cyclobenzaprine, prednisone and hydrocodone; all via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for an unspecified indication. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient stated, "First, I had COVID back in early December and then on 12Mar2021, I got my first vaccine and I have lot of aches and pain and very foggy brain. I was just with the 'chiropractor' and he was just with me and I stood up and we were talking and I just got super dizzy and almost passed out, I just don't know. I missed, I can't even focus." When clarified the concern, the patient stated, "When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy and almost passed out, luckily there was a chair to catch me. So, my concern is, do I get the second vaccine if I already had COVID, should I didn't had this first vaccine since I already tested positive? When I had COVID, I was very cloudy in the brain. I don't know if this is a part of side effect, I am trying to find out if I can get the second vaccine." The patient experienced kidney stone. The lab data is clear, upon checking, the blood and urine samples. CAT scan has been done and the report is clear. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

2am woke up with nausea, severe headache, chills and sweats. Vertigo upon standing. Drank water and slept little till 8 am. Took 1 Tylenol at 8, and noon. Had a morning nap and afternoon nap over an hour and normally cannot nap. Took 2 Ibuprofen at 4pm. Aches in joints along with previous symptoms mentioned all day and subsided significantly by 8pm. Was unable to function normally and slept or laid down all day. Felt normal the next morning. Had no arm pain at injection sight at all this time.

8April 10:00AM-11:00AM prickly warm sensation on shoulder, face, near injection site also arms and hands 11:15AM-1:00PM Itchy bumps on both forearms, heart jumps, headache, metalic taste 1:10PM sudden fatigue, sleeping and drinking water for the next 40hours through to 7:00am 9April 3AM severe headache wakes me, I have a fever. 99.1 fever continue to rise throughout all of 9April and head ache does not lessen until after 7am 10 April 4:15AM vomiting 4:49AM HeadAches in every brain cell and in eyes, Temp 99.7 8:20 am temp 99.8 12:00pm temp 99.9 7:00pm temp 100.8 took 2 tylenol 8:40pm temp 100.0 10April 1:11AM temp 97.4 headache persists 7:00am Headache starts to lessen, fatigues persists 1:00pm fatigues abates

Patient reported nausea, headache, "weird" sensation within 15 minutes of vaccination. Had dry heaves; IV started, BP 173/101; given Zofran and transported to ER by EMS.

10pm started feeling cold. Then got the shakes for 2 1/2 hrs. Had fever. Woke next morning (Wednesday), nauseous, fever. Foggy and tired Arm painful and couldn?t lift it past waist. Had fever 100.2 Wednesday and Thursday. Still felt tired. Friday morning woke up feeling back to normal

1st reaction - Day 1 As I was walking to my vehicle, after waiting my 15 minutes, I had an awful metallic taste in my mouth. I had to spit out the saliva, which helped, but it still lingered for a few minutes. 2nd reaction -Day 1 After several hours, I experienced swelling in my right arm, and diarrhea. I also had insomnia, and slept very little the night of the shot. Day 2 I had loose stools, slight nauseous feeling most of the day. My body odor smelled like onions. I also had bad muscle aches and fatigue. That night, I had insomnia again and slight chills. Day 3 Still had loose stools, fatigue and muscle aches. The onion smell comes and goes. I experienced excessive urination throughout the day (about once an hour, which is not usual for me). Day 4 Muscle aches and fatigue are gone, Day 5 Excessive urination again. Onion smell comes and goes.

Pt states feeling dizzy post-shot. Also complaining of tachycardia. Pt appears mildly anxious. SBP checked = 174. Patient states she has high blood pressure. HR checked 80, appears regular. Patient given benadryl.

Lightheaded during the day, dizzy spells upon laying down and getting up, foggy headed. Started about 24 hours after shot.

Day 2- started out fine, at 9am got bad headache, then started feeling very tired and dizzy, layed down woke up around 1pm started feeling nauseated ran a fever, stomach was hurting (whole abdomen) had diarrhea had no appetite could not even eat more than 1 bite of a dry bagel. Was so tired couldn't do anything but sleep. Day 3- same symptoms as above but no fever, stomach a little better. Finally at 8pm ate a banana and husband made me eggs. Took until almost 10pm to eat eggs. Day 4- felt much better but still tired and a little weak but was able to walk around house a little and had yogurt for lunch and was able to eat a regular dinner.

Severe chilling followed by a panic attack. The next day experiencing pain on the outside of the right knee. By 3rd day pain noticed in left and right arms, moving across the top half of the back above the shoulder blades. Excruciating pain by p.m. of the same day preventing me from sleeping. Unable to use arms to get a glass out of the kitchen cabinet. Pain has moved around causing pain and swelling in joints, affecting the right and left arms, wrists, hands, legs. Went to UTC where I was given a steroid shot. The shot lasted about 24 hrs. and right back to the above symptoms. Going to physician today hopefully for some lab work. 11 days of pain!

Thursday 4/8/2021: Similar Symptoms to previous Vaccine except it was within the 60 minutes. Bumps of Throat, Hard to Swallow, Tongue felt Swollen and warm. Took 2 Benadryl at 5:30P an hour later it was easier to swallow, took 2 more Benadryl at 9:30 PM . Friday 4/9/2021 Similar Symptoms Thursday Bumps on Throat, Tongue felt swollen and warm but easy to swallow But NO TASTE. Took 1 Benadryl every 4 hours. Saturday 4/10/21 Taste Returned, still have bumps on throat and mouth not as warm, queasy stomach and headache. Tylenol only Sunday 4/11/21 Better but still have bumps on throat, headache, queasy stomach and bloated. Monday Better yet bumps on throat only.

Pt developed chest tightness shortly after vaccination. She believes that her chest symptoms are consistent with anxiety. She notes anxiety with injections and vaccines in the past. BP 160/90, HR 82, SP02 99%. R: 16. EMS services was recommended but the pt declined and elected to drive home. She is aware of the risks of a potentially serious undiagnosed medical issue.

First few days, arm pain. Since April 1, I've had much more knee pain. Tremendous and it is affecting my daily routines.

Felt fine after vaccine, no ill affects other than a very mildly sore arm. 9 days later woke up feeling fuzzy headed, mildly nauseated, generally not well. Later in the day I had bouts of diarrhea and persistent stomach ache (just below ribs), mild nausea?into the night and wee hours. Woke the second day feeling well.

Extreme nausea since shots. Had 2nd shot on April 3, 2021 and Nassau has been so bad and so constant that I am unable to do my daily routine. I have to wonder if it has caused a flare up of pancreatitis

2 days after the injection i started getting real dizzy, i had to call someone cause i nearly passed out. they took me back to the office and let me sit there till someone came to relieve me. then i went home. that was on Friday Jan 29, 2021. I stayed out of work for 3days, went back to work on Mon Feb 1, 2021, still being dizzy i continued working till my days off on Wed Feb 3 and Thurs Feb 4,2021. went back to work Friday Feb 5,2021. had to leave work again because of severe dizzines. Called immediately to see if i could get an appointment and got one Saturday Feb 6,2021. then tried again to return to work again on a MondayFeb 8, 2021, worked through with vertigo again till days off Wed Thurs Feb 10 & 11,2021. Tried to work again same thing on Fri Feb 12, 2021. Left work again and been out ever since.

passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs and muscles (some short and some long duration); rash; cold; night sweat; no energy; intense dreams first night; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955) via an unspecified route of administration, administered in arm left on 30Mar2021 13:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included zolpidem tartrate (AMBIEN). The patient was healthy. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received the first dose of BNT162B2 (Lot number: EN6199) in the left arm on 11Mar2021 11:00 AM at the age of 62-year-old for COVID-19 immunisation. The patient experienced passed out twice, intense, rapid and irregular heartbeat (prolonged), intense pain in various organs and muscles (some short and some long duration), rash, cold, night sweat, no energy, intense dreams first night; all on 30Mar2021 with outcome of not recovered. Doctor appointment was scheduled. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether treatment received for the events.

eyes rolled back/passed out; my throat area under my jaw line started to hurt; my left leg was achy and tingly; my left leg was achy and tingly; headache; nauseated; weak; fever; just didn't feel good; sick; became rigid; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer-BioNTech, lot unknown=true, lot unknown reason=unable to locate or read the details) via an unspecified route of administration in right arm on 26Mar2021 11:45 (62-year-old at vaccination date) at a single dose for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy (HCM), a bruit, ventricularomegaly, gastrointestinal (GI) issues, many female issues (before she got a hysterectomy), cancer activity, hepatitis C (Hep C), COVID-19 since 18Mar2021 (diagnosed as extremely positive, remained sick until 25Mar2021), and allergies to medications, food, or other products included Motion sickness meds. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was reported as yes but unspecified. About 25 minutes after the vaccine, her throat area under her jaw line started to hurt, her left leg was achy and tingly, and she was started to get a bad headache. She became nauseated and weak. She made it home, took paracetamol (TYLENOL), and got in bed. Saturday her headache was on steroids, she had fever, and just didn't feel good. Later that day, she was so sick she went to the bathroom and she guessed she passed out. Basically, her husband said he found her on the floor after he heard a thump. He asked me what was his name. He said she responded correctly, but then her eyes rolled back, she became rigid, and he called 911. she knew 2 sets of paramedics arrived w/ambulances. They monitored her vitals and stayed until she was normal. They were willing to take her to the hospital, but offered other options for her husband and she to consider. They suggested she see her Primary care doctor (she did on 29Mar2021). Her doctor believed she should not take the 2nd dose of the vaccine. Adverse event start date was 26Mar2021 at 12:30 pm. AE resulted in doctor or other healthcare professional office/clinic visit. It was reported no treatment received for the adverse event. The outcome of event was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.

About 20 minutes after vaccine, started seeing visual auras, felt flushing. Auras got worse and filled vision and felt really disoriented. After about one hour., auras stopped and disoriented feeling subsided.

AFTER 11 DAYS, I'VE GOT A STRANGE TEETH ROOT INFECTION (HAD AN URGENT ROOT CANAL TREATMENT) FOLLOWED BY A HERPES ZOSTER OUTBREAK AND A "COVID ARM" WITH REDNESS, SWOLLEN AND PAIN. THE HOTLINE CORONAVAX IN SWITZERLAND, GAVE ME THE ADVISE TO GO TO THE PHARMACY, EXPLAIN MY EVENT TO THE PHARMACIST. HE LOOKED AT MY "COVID ARM" GAVE ME A POMADE AND GAVE THE ADVISE TO GO THE URGENCY IF IT DOES NOT GET BETTER AFTER 3 DAYS. NOW AFTER 14 DAYS, I AM STILL FEELING A LITTLE CRANKY. MY HEALTH PROFESSIONAL DOCTOR WITH HOMEOPATHIC APROACH, GAVE ME THE ADVISE NOT TO TAKE THE 2ND SHOT. WHAT SHALL I DO?

HOT ZINGING FEELING RIGHT ARM, SHOULDER AND CALF ONSET Immediate / DURATION 30 minutes INJECTION SITE PAIN day 2 / 2 days TIREDNESS day 2/ ONGOING SEVERE HEADACHE AT PREVIOUS CONCUSSION SITE day 3/ ONGOING but no longer severe CHILLS day 2 / 2 days SEVERE JOINT PAIN AT DAMAGED JOINTS day 2 / 2 days LOW GRADE FEVER day 2 / 2 days VERTIGO/NAUSEA/VOMITING day 2 / 2 days (I LOST 4 LBS) DIZZINESS Day 2 / ONGOING FEELING GENERALLY UNWELL day 2 / 2 days FACIAL PALSY RIGHT SIDE INLCUDING EYE SOCKET day 1 / BAD ON DAY 1, LESSENING EACH DAY BLURRY VISION RIGHT EYE Immediately / ONGOING INTERMITTENT HYPERTENSION Day 3 / Lasted all night. I couldn't sleep. Was sort of vibrating. Got up to 168/107. Was down to 116/88. Now bouncing around and up again at 150/96. My norm is 110/70ish. When I got the shot I had to sit with an EMT for 90 minutes because of the facial palsy. Then I was massively sick for 3 days. Vertigo, dizziness, and vomiting were the worst. Now the pain at concussion site and continuing dizziness is lousy, plus the BP increase started last night and is bouncing around. Maybe it will settle down like all the rest of the side effects. Seemed like each day brought on new side effects and they last from 12 to 48 hours.

Ever since receiving vaccine, I have been unable to stay asleep for more than 1or 2 hours at a time. Also, very vivid dreams. Both of my 2 brothers are having the exact same side effects

body aches, chills, headache, fatigue, night sweats, loss of appetite, severe pain, hallucination, talking in sleep, cough

I noticed a rash on my torso on Monday night - 4/12/21. It reminded me of chicken pox. It became increasingly itchy. On Tuesday it was more pronounced (redder) and itchier. I had difficulty sleeping on Tuesday 4/13/21 evening and the itching and redness became even more intense. I called my health care provider on 4/14/21 and was told to take Benadryl and/or Claritin and apply ice pack to itchy patches and avoid hot water showers. I used an ice pack throughout the day on Wednesday. On Wednesday evening I took 1 Benadryl at 9 p.m. and applied an ice pack throughout the night to sleep. I used the ice pack throughout the day on Thursday and took 1 Benadryl at 9 p.m. on Thursday 4/15/21. The itchiness, redness and spots were decreasing throughout the day on Thursday. I used an ice pack overnight for relief to sleep. When I woke on Friday 4/16/21 the rash was about 95% gone and the itchiness greatly reduced. I was comfortable, had no spots and had normal energy starting Saturday 4/17/21. The rash never got hot to the touch, just very itchy and uncomfortable.

Severe migraines for 4 days. Last two day could not get out of bed. Vomiting and could not eat. Then 2 days of lower grade headaches. This has been followed with some hallucinations at night just before bedtime.

TIA - mini stroke/transient ischemic attack. Started with loss of ability to speak/understand, weakness of left arm and leg, headache, slurring of words - 3 days in Hospital - resulted in damage to memory, confusion, weakness in left arm+leg, severe headaches - ongoing, but slightly improved after 3 weeks. Also diagnosed with acute cerebrovascular accident.

Approximately two days after receiving the second dose of the vaccine. my left arm and shoulder became very sore. I have trouble lifting it and cannot lay on that side without pain.

Severe Headache, Vomiting, high fever over 103 (my base temp is always 96.5-97)complete body aches, chills, lightheadedness tiredness. Headache better after 24 hrs, but now 4/24 it is back. The fever went down to 100 but today is inching back up. Still achy and extremely tired and I have lightheadedness and fainted today. Off and On I feel chest pain, but it could be anxiety.

I felt a little woosy; This is a spontaneous report from a contactable other health care professional (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1st via an unspecified route of administration, administered in Arm Right on 05Apr2021 13:00 as single dose for covid-19 immunisation. Medical history included Severe back problems. Patient had allergies to Chocolate. Concomitant medication was not reported. On 05Apr2021 01:15, patient felt a little woosy. She was not pregnant at the time of vaccination, did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination. She was not received treatment for the adverse event. Patient was not diagnosed with COVID-19 Prior to vaccination, since the vaccination, not been tested for COVID-19. The outcome of the event was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

immediately started with tingling on tops of both feet particular on left foot/ tingling in toes; I am having trouble with my left foot; it's a sensation of tingling that is weird; tripping periodically; It doesn't hurt but it could hurt/pain threshold/foot; it is like I have drop foot / Like foot drop; This is a spontaneous report from two contactable consumers (patient and her husband). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ENS208 (patient's husband also reported that the 3rd digit could be a 6 or an 8, patient added that it was EN8208 but her husband stated he was less confident)), via an unspecified route of administration, administered in Left Arm (also reported as left shoulder) on 11Mar2021 at 15:00 (at the age of 62-year-old) at single dose for there's a pandemic going on. Medical history included she walked everyday and exercise a minimum of 45 min/day, for years, 20 years; high blood pressure; her condition, there was something in her esophagus and there was a problem; had a problem with her parathyroid and they removed it, there were 4 nodes and they took 2 and there were still 2. Patient's mother is 99 and had an accident. Ongoing concomitant medications included lisinopril from an unspecified date (reported as has been on 10 years or so, so a long time) for high blood pressure; colecalciferol (VITAMIN D) from an unspecified date (reported as has been on for about 3 years) as she had a problem with her parathyroid and they removed it; alendronate sodium (ALENDRONATE) from an unspecified date (reported as has been on for approximately 3 years) for bones and back to make sure she has enough calcium in her bones; pantoprazole from an unspecified date (reported as has been on around 3 years but she does not remember, it has been about three years) for her condition, there is something in her esophagus. Despite all of these medications she is healthy. Patient reported that she did not know if this was vaccine related or not, but the timing was. She got the vaccine on 11Mar2021, and immediately started with tingling on tops of both feet particular on left foot on the way home, which was side she got vaccinated on. She got tingling immediately following vaccination on 11Mar2021, and it's worse now but stable, not getting worse, it was like she have drop foot, sort of like that in 2021, she had to remember to lift her foot. She exercise. She walked everyday and exercise a minimum of 45 min/day, for years, 20 years. She had been walking and now she was having trouble with her left foot in 2021. Tingling on feet started right away, she drove back from vaccination site about an hour. She was able to drive and walk, it's not stopping her life she was tripping periodically mostly on her left foot in 2021, because she was not always conscious of lifting her foot. It's not painful, it's a sensation of tingling that is weird, it did not hurt but it could hurt, if it got worse it could be in the pain threshold, it's just in the annoying threshold in 2021. Like foot drop, like nerve damage on the top of left foot in 2021. She thought that if she didn't have a vaccine, she would say it felt like a nerve damage sort of thing, in both feet but predominantly in left one giving her trouble. Patient's husband added that the tingling was not excessively painful, it easy for him to say it was not painful. Tingling in toes was primarily on the left. She added that the tingling was not debilitating but it was just her husband she did not know if it had anything to do with the covid19 vaccine. No previous immunizations with suspect product. No additional vaccines administered same date. No AE required visit to Physician's Office or Emergency Room. No prior vaccination within 4 weeks. Family medical history relevant to AE was none. No investigation assessment for this, she had a physical next week which was just standard and just a standard battery of tests. Therapeutic measures were taken as result of all events included lifting her foot. The outcome of the event tingling was not recovered, outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.

Extreme joint pain, knee & hip, affecting ability to function in normal activities of daily living, mobility, etc. And also requiring opioid pain medication daily in order to treat/manage debilitating joint pain.

In pain; Could barely eat; feeling full; Taste buds are completely shot; muscles ache; can barely move when stand up; muscle weakness; really weak; This is a spontaneous report received from a contactable consumer (patient husband). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Lot number: ER8737, Expiration Date: Jul2021), via an unspecified route of administration on arm right on 02Apr2021 probably about 13:30 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were none. The patient had no family medical history. No additional vaccines administered on same date of the Pfizer Suspect. The patient did not visit to Emergency room or Physician office. The patient had no prior vaccinations (within 4 weeks) and no adverse events following prior vaccinations. It was reported that, the caller is a consumer reporting he and his wife had their first dose Pfizer Covid Vaccine on 02APR2021. Caller reports his wife experienced the same side effects as the caller. Caller's wife was really weak in Apr2021 and was experiencing all the same symptoms as the caller except no chills and no difficulty sleeping. Reports when the wife lays down, she was out cold asleep, and has no difficulty sleeping. The caller states the afternoon after receiving the Pfizer Covid Vaccine when leaving the administering facility, so far nothing bad had occurred. Caller reports he and his wife stopping to get something to eat on the way home from the Vaccination administering site, and in his case he could barely eat on 02Apr2021. This was the same for his wife. It was like it was not digesting on 02Apr2021. She has a feeling of feeling full and not being able to eat on 02Apr2021. Her taste buds are completely shot. Whenever she eats something it taste like cardboard. Mentioned his wife tries to eat because she needs to. She cold, barely finishes her food at the restaurant they went to after getting the first dose. It was like their food was so bland. Caller confirms some of the symptoms he reports are the same for caller's wife. Reports caller's wife is similar to him. She has muscle aches and can barely move when stand up in Apr2021. Caller explained his muscles ache like being beaten with a baseball bat and it's the same for his wife. Muscles ache constantly. Confirmed she was also having muscle weakness in Apr2021. Confirmed his wife was really weak. She can barely stand up. If she sits down on the chair or in a car in the drivers seat, its almost like caller was going to fall asleep. The outcome of the event was reported as unknown. No follow-up attempts are needed; No further information is expected.

Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Severe

Just want to let you know my tinnitus increased increasing my anxiety and making it difficult to relax and sleep. My hearing test just showed hearing decrease from my last test. And subjectively I feel a loss of hearing and difficulty sleeping I did not have before. I thought you should know and would like to know if others are getting tinnitus or increased tinnitus.

Injection site began to hurt within the 15 minutes of wait time after the injection. Left arm was very painful within 24 hours of injection and physically exhausted Tinnitus set in approximately two weeks after second injection. Accompanied by pain in both ears, sometimes throbbing. The tinnitus is day and night and sleep is affected. I have contacted my doctor asking for help.

Symptoms: Patient reports balance issues since receiving her COVID vaccine. (received vaccine 4.16.21) She fell the first evening (4.16.21) after losing her balance. She denies significant dizziness, weakness or numbness. She fell again yesterday (4.27.21). (called nurse triage line to report on 4.28.21) She also reports worsening of her urinary incontinence and isn't sure if its related. She reports a headache only because she fell hit her head when she fell. Balance issues-recent fall twice concern seeking medical advice Noticed no balance control Noticed increased of dreams of falling while sleeping first fall on same day of vaccine 7:30pm second fall yesterday -around 10am Symptom duration: couple days Recommended ED or Urgent Care - no follow up or visit by patient at this time of reporting (evening 4.28)

Nausea, dizziness, lump in throat, rapid heartbeat, suppressed breathing, headache, muscle pain, chills, joint pain, fever, injection site swollen, hot, and red size of 50 cent piece

felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell hit self on head; bruises on face; had burst lip; diarrhea; leg pain; fainted; seizure; felt hot; chills/shaking.; This is a spontaneous report from a contactable consumer (patient herself). This 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration in the left arm, on 13Apr2021 at 21:00 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EP6775 MS 389) administered via an unknown route in the left arm on 17Mar2021 (at 10:00 AM) for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included gastritis and anxiety. Past drug history included allergy to mirtazapine (REMERON). Relevant concomitant medications included diazepam (VALIUM), vitamins and probiotics. On 13Apr2021 at 23:00 the patient had chills / shaking. On 14Apr2021 at 02:00 AM, she felt hot. She went to bathroom, felt low blood pressure, weak, and fainted. Woke up, felt disoriented, not know where she was, confused. When fell hit self on head, lip, nose, and eye. She suffered various bruises on face. May have had seizure, had burst lip and felt was biting. Then suffered diarrhea that day. She also experienced leg pain. She went to the doctor on 16Apr2021. On unknown date, blood work up was done and results were not provided. The patient was recovering from the events. Information on the lot/batch number has been requested.

My nasal passages, throat, and bronchial tubes started to swell up; feeling faint; general malaise; My nasal passages, throat, and bronchial tubes started to swell up; My nasal passages, throat, and bronchial tubes started to swell up; brain fog; This is a spontaneous report from a non-contactable consumer (patient). A 62-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 08Apr2021 14:00 (Batch/Lot Number: ER8729) (at the age of 62-years-old) as single dose for covid-19 immunization. Medical history included known allergies: penicillin from an unknown date. The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2, dose 1, administered in arm left on 18Mar2021 01:45 P.M. (Batch/Lot Number: ER2613) (at the age of 62-years-old) for covid-19 immunization. The patient did not get COVID prior vaccination and did not receive COVID test post vaccination. About five minutes (as reported) after the patient received the shot, she started feeling faint on 08Apr2021 02:15 P.M. Her nasal passages, throat, and bronchial tubes started to swell up on 08Apr2021 02:15 P.M. Taking a decongestant when she got home helped that. For a few days she had congestion and brain fog along with general malaise. Treatment received included she took decongestants. The outcome of the events was resolved in Apr2021. No follow-up attempts are possible. No further information is expected.

She felt like she would pass out if she didn't feel the black out sensation coming on; fever; dizzy; body aches; She felt like she was on a boat/ she was not feeling right; had soreness in her arm; has zero energy; She fell asleep in her sunroom and got up around 3:00PM; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158; Expiration Date: Jul2021, NDC not known), via an unspecified route of administration, administered in right arm on 16Apr2021 at 10:00AM (at the age of 62-year-old) at single dose for prevent Covid 19, she wanted to feel safe traveling. No additional administered vaccines administered on same date with the Pfizer vaccine considered as suspect. Medical history included ongoing rheumatoid arthritis and prior to receiving her Covid 19 vaccines she reached out to her rheumatologist to see if she would be ok getting the Covid 19 vaccine while taking her medications, her rheumatologist told her she would be ok to receive the Covid 19 vaccine. Ongoing concomitant medications included methotrexate injection and hydroxychloroquine. No prior vaccinations within 4 weeks. The patient previously was made to get a flu vaccine for work about 20 years before for immunization, the flu vaccine made her violently ill, she ended up having to go to an Urgent Care, she had to call her mother to come get her, she could not even get out of bed, she had to stay home a week from work because she was sick; she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Mar2021 (at the age of 61-year-old) at single dose for COVID-19 immunization and experienced fever, everything in her body ached, every time she bended over, if her head got below her shoulders to pick something up she would black out and vertigo. When she received her second Covid 19 vaccine her symptoms started again on 16Apr2021. She felt like she would pass out if she didn't feel the black out sensation coming on. She didn't know how long she blacks out for. She tried to grab a hold of something, for example, she was in the shower shaving her legs and she reached down to shave her legs and she could feel herself starting to pass out. She had a ledge or seat in her shower and she grabbed the shower wall and lowered herself to a sitting position on that ledge in her shower. The feeling passed and she tried to shave the other leg and the same thing happened again. When she's sitting on her sofa and she bended down to the floor to pet her small dog, all of a sudden she could feel herself moving forward like she was going to fall forward. Her husband grabbed her arm and pulled her to an upright position and asked her if she was ok. She reported her normal body temperature was 96.9 degrees Fahrenheit on an unspecified date. She was not someone who ran 98.6 degrees Fahrenheit. She reported her temperature had been about 98.8-98.9 degrees Fahrenheit on an unspecified date and that to her was a fever. She was still running a fever. She reported she had been afraid to drive because she was afraid she would pass out. She knew she did not have vertigo. She did a have a yearly check up with her primary care doctor and she was going to talk to her doctor about what's happening. She received her Covid 19 vaccine with her husband at about 10:00AM. Shortly after when she and her husband were driving home, she told her husband she was dizzy on 16Apr2021. She felt like she was on a boat. Even if she looked up or bent over was when she got dizzy. Her fever started right away after her vaccines on 16Apr2021. She also had soreness in her arm and everything in her body aches on 16Apr2021. She had zero energy on 16Apr2021. She was still feeling this way now. She fell asleep in her sunroom and got up around 3:00PM on 16Apr2021. Not any adverse events required a visit to Emergency Room nor Physician Office. The outcome of the event fell asleep was unknown, outcome of the other events was not recovered.

Major joint pain and inflammation in knees and ankles Major tiredness. Did not wake up on May 7. My husband had to call 911 as my Blood sugar dropped to a low of 17 I almost died

having faint spells; blood pressure is a little bit higher than normal; Feeling kind of funny; had severe headache; This is a spontaneous report from a contactable healthcare professional, the patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8727, second dose) solution for injection intramuscular in the left arm on 25Mar2021 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. Medical history included thyroid disease (diagnosed with probably 20-21 years ago) and blood pressure increased (takes blood pressure medicine). Concomitant medication included hydrochlorothiazide for blood pressure increased began taking this 4 or 5 years ago. Historical vaccine included BNT162B2 (first dose, lot EN6200) for COVID-19 vaccination on 04Mar2021 with no adverse effect reported. On 25Mar2021, the patient was feeling kind of funny and had a severe headache. In Apr2021, the patient had faint spells and blood pressure was a little bit higher than normal at 137/80 which began after the second dose Pfizer Covid Vaccine. The patient stated she never felt like fainting before in her life. Her blood pressure was never over 150 and can't keep blood pressure under 130 for some reason. The outcome of the events feeling kind of funny and headache was unknown. The outcome of the events faint spells and blood pressure was a little bit higher was not recovered. Information on batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event faint spells and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

This is a spontaneous report received from a contactable nurse (patient) via a Pfizer-sponsored program. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206), via an unspecified route of administration in the right arm, on 10Mar2021, as 1st dose, single, for COVID-19 immunisation. Medical history included ongoing fibromyalgia (diagnosed in 1996), ongoing allergies from 1981, ongoing food allergies and chemical allergies, ongoing allergy to alcohol, ongoing hypothyroidism from 2012, ongoing pre-diabetic from 2012, Lyme disease for 11 years before being correctly diagnosed and treated, concussion in Sep2019, and post concussion syndrome in Sep2019. The patient previously took nalbuphine hydrochloride (NUBAIN) in 1981 and experienced anaphylaxis; and paracetamol (TYLENOL) and was very sensitive, had rash and high blood pressure. Within the first 15 to 20 minutes following the administration of the first dose of the Covid-19 vaccine, on 10Mar2021, the patient's face and ears got very red, flushed, and itchy. The patient reported that she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction. She reported that she has had glycol before and has never reacted quite like that. The flushing, redness, and itchiness of her face and ears subsided within an hour and were gone by 4 hours. Her allergist instructed her to take 2 Zyrtec before getting the second dose of the Covid-19 vaccine. After her face and ears became flushed, red, and itchy, she ended up having a really bad headache that continued until the next day. Her headache was severe for about 12 hours and continued for a total of a day and a half. She stated that her headache was more like a migraine during the 12 hours when it was severe. It felt like a migraine, but worse. On 10Mar2021, the patient reported that she experienced flu-like symptoms like being nauseous, had dizziness, achiness all over, and was not feeling well, her post-concussion syndrome was triggered and had more headaches, dizziness, nausea. She reported that things have been going awry in her body since she had the COVID-19 vaccine. She reported that the increase in headaches seemed to have improved, but the nausea and dizziness have in some ways improved and then some days it feels like "here we go again" when it hits. About a week after she received the first dose of the Covid-19 vaccine, in Mar2021, the patient noticed a change in her urination. It wasn't severe or anything at that point, she just felt like she was not able to release the urine (urine retention). She thought to increase her intake to see if it would help her urinate and it didn't seem to help much. She received a prescription on 26Mar2021, and during that week, she noticed that she was having more issues with some burning during urination and was developing pelvic pain and pressure. The patient stated that the scent and color of her urine looked fine. She reported that the frequency started to increase with not much urine coming out. When she finished her antibiotics about 7 days later, the urine retention had really improved and went away at the end of March. In the morning of 26Mar2021, when the patient woke up, she had blood in her urine and clots. The clots were about the size of a pea and a couple were about the size of a dime. The blood and blood clots in her urine were what made her go to the doctor. She reported she has never had blood in her urine that she remembers. She was put on Macrobid for 5 days. She reported that Macrobid wasn't relieving enough of her symptoms and her provider ended up adding a couple more days. The patient reported feeling more worn out in Mar2021, since she received the first dose of the COVID-19 vaccine. This did not improve and some days it was worse. The patient did not have the energy level and stamina that she used to (Mar2021). She reported that whether it's combined with the retriggering of her post-concussion syndrome, it is significant for her life. She was also not eating well and had lost some weight (Mar2021). She reported that her appetite is improving but it is still not normal for her. She mentioned it was harder for her to want to eat something because of feeling nauseated. The patient assessed the events "face and ears became very flushed, red, and itchy", headache, "headache was more like a migraine/felt like a migraine, but worse", "post concussion syndrome was retriggered", "blood in her urine and clots", "not eating well and had lost some weight" and "feeling more worn out" as serious (medically significant). The patient recovered from "face and ears became very flushed, red, and itchy" and "she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction" on 10Mar2021; headache, "headache was more like a migraine/felt like a migraine, but worse", "she was not able to release the urine (urine retention)", "blood in her urine and clots", "flu like symptoms", dizziness, "achiness all over", "pelvic pain and pressure", and "some burning during urination" in Mar2021; and was recovering from "not eating well and had lost some weight". The outcome of the remaining events was unknown. The patient assessed the causality of events headache, flu like symptoms, nausea, "face and ears became very flushed, red, and itchy", dizziness, "post concussion syndrome was retriggered", and "not eating well and had lost some weight" as related to BNT162B2.; Sender's Comments: Based on the information in the case report and a plausible temporal association, A possible causal relationship between urinary retention, hemorrhage urinary tract and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

She got her vaccine and within 10 minutes she felt like her heart did a big woosh and was sitting with her husband and told him that it was hitting her blood stream as she had not had the reaction since starting some medication due to lupus. The first hour it was fairly overwhelming wooshing sensation that made her feel uncomfortable and restless, and then got less. Over the course of the week it continued to happen and did not feel right. She called her PCP and by the time she got to see him on 5/20/21 it had been a month, but had not worsened to go to the ER. She had an EKG that showed acquired long QT syndrome, and told her that she could not get the 2nd vaccine. He said that if she got hte 2nd vaccine that there was a likelihood that she would develop Torsades de pointes and that it could be life threatening. Now he has to be careful on what to treat her due to this condition. He told her to take really good care of herself and to continue take her medications and if it got worse to go to the ER. She will FU with him in a month and he would continue to check EKG's to see if it will go away or not. She is more tired and if she goes up and down the steps she is out of breath much quicker than before this condition. She had several normal EKG's in the past that he compared the last one with and she did not have this condition on previous EKG's. She wishes that they would put out information for people who have autoimmune issues to publish these reactions to be watchful of reactions. Feels they need to update the website to report similar side effects.

Five days after the second COVID dose I experienced what I thought was motion disturbances similar to a head concussion (week long symptoms) I had six months ago. When I looked into what brain fog was with the vaccine it was very evident that was what was going on. I actually did not realize how bad it was until much later when it cleared. Difficulty focusing and having to repeat processing events that has never happened before. Difficulty sitting and following conversation after an hour need to get up and leave. Still some motion dizziness when turning head fast or downward such as putting on shoes.

Onset of strong nausea, chills with fingertips turning blue and fever. Brain fog and exhaustion made it difficult to get up throughout the evening into the next day. Nausea, headache and low-grade fever continue to linger and it has now been 3 full days. Developed an "angry" looking rash in lower left groin area - large red splotches with some itching and discomfort. Noted rash on the day following the injection and it hasn't diminished as of today.

Approximately 5 minutes after shot was administered into my left upper arm, as I sat down to wait my 15 minutes as required, I started to feel a racing heart, lightheaded, shaky, nauseous and strange sensation in my body. I was with my mother and my husband. My husband noticed I was struggling and called over the paramedic on staff. He came over and asked me questions, as to what I was feeling, he brought over a bottle water and asked if I wanted some Cola for the nausea, apparently it helps with nausea. At first I didn't want it, then I ended up taking a few sips. The entire episode lasted approximately 30-35 minutes, and I felt my heartrate returning to normal, however, I continued to feel out of sorts, shaky. Upon returning home, the entire evening of the day in question, I felt a heaviness in my head, ache over my eyes, then my body continued to feel strange, I was very tired, and of course, my arm began aching, I barely slept through the night, feeling strange sensations in my body, aching arm, and headache, nauseated. I had taken Tylenol after getting home from the vaccine shot. I finally got what I remember, maybe 2 hours of sleep, waking up to go to the bathroom, and my legs felt like cement! I could barely walk! Pain was radiating up the back of my legs, thighs, and buttocks. I held myself along the wall to the bathroom and could barely bend. After using the bathroom, I once again felt a tremendous heaviness, cement-like legs, barely making it back to the bed. Throughout the entire day I could barely walk, severe muscle spasms lower back, thighs stiffness, down the back of legs, severe pain. I contacted my doctor, told him of what was happening and he stated not to go back for the 2nd shot due to my issues with the 1st. This has been ongoing since April 28, 2021, today is May 24, 2021 almost one month later and I am no better. Although I have had Fibromyalgia for several years and Chronic Fatigue Syndrome, since the vaccine, it has triggered a complete relapse of my condition, making it unbearable, painful. I have been living on pain meds, and icing/heating on and off. Now requiring physical therapy.

I noticed I was experiencing tinnitus / ringing / buzzing in my ears about 3-4 days after receiving the first Pfizer dose. It was rather pronounced, particularly at night. I have also seemed to have increased level of insomnia as I try to get to sleep. It hasn?t been terrible but both symptoms can be annoying at times. The buzzing in my ears can sometimes be hardly noticeable but at other times it seems a bit loud, particular when I am trying to get to sleep. It sounds like what they call pink noise. It does not seem to be affecting my hearing acuity.

Headache; fever; aches; sleepiness; brain fog; flu-like symptoms (Just like Covid that I had); This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right (at the age of 62) on 22Feb2021 10:00 (Lot Number: EL9267) as single dose for covid-19 immunisation. The patient medical history included covid prior to vaccination. No known allergies. Concomitant medications included imipramine, propranolol. The patient experienced headache on 22Feb2021 14:00, fever on 22Feb2021 14:00, aches on 22Feb2021 14:00, sleepiness on 22Feb2021 14:00, brain fog on 22Feb2021 14:00, flu-like symptoms on 22Feb2021 14:00. No treatment received. No covid tested post vaccination. The events outcome was recovering. No follow-up attempts are possible. No further information is expected.

(5/26) received 2nd covid vaccine at facility. Woke up on 5/27 feeling bad, left arm sore with the feeling of a tennis ball in my left arm pit (axilla) and sore or tender to touch. On (5/27) evening slept all night with left arm elevated on pillows. (5/28) Went to Urgent care /known side affect symptom (lymphadenopathy in left arm axilla d/t covid vaccine #2). When asked what I could take as pain tablet; Ibuprofen was recommended d/t trx of inflammation. As you can see from my date of vaccination, I have been reluctant to get this vaccine d/t side affects and my own known medical history. To my knowledge, i have not had Covid and have always worn a mask. So here I am.....

She got her vaccine, she did not have any reaction that day. Her arm hurt a little when she was sleeping. She woke up the next morning and had severe chest pain, which did not stop no matter what she was doing during the day, even sitting down. The following day when she woke up everything was back to normal. She waited one additional day to make sure it was not a microvascular issue she had, and did not get it again and still does not have any issues. She did call her cardiologist who told her not to take the 2nd vaccine. The day they were going on she just took her regular medication and monitored her heart rate and her BP.

Extreme Fatigue/Lethargic - Wake up tired and not refreshed. Constant fatigue and sleepiness. Inflammation beyond belief. Pain in places that I have never felt. Left shoulder, Right shoulder, Right leg and left leg tendons. I am struggling to to normal activities. Increase in the intensity and severity of the pain, and tenderness and soreness associated with fibroymalgia. Example: Woke up at 7 am, had breakfast, Mani/Pedi Appt at 11 am, Could hardly stay woke for Mani, but slept through the Pedicure. This is getting to extremely overwhelming for me to deal with.

burn feeling on her arm; pain at the injection site; shoulder and arm have been hurting; shoulder and arm have been hurting; having a hard time getting dressed and lift her arm; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date: unknown) via an unspecified route of administration on 30Apr2021 (at the age of 62-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccines included the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) on 13Apr2021 as single dose for COVID-19 immunization. She stated that the nurse who administered the 2nd dose asked her to pull her arm down and had burn feeling on her arm when she received the shot on 30Apr2021. She had pain at the injection site. Her shoulder and arm have been hurting ever since she got the 2nd dose. She was having a hard time getting dressed and lift her arm in 2021. She wanted to know recommendations to manage the symptoms and how long usually the symptoms last. The outcome of events is unknown. Information on the lot/batch number has been requested.

hearing loss in both ears; hypersensitive to sound; painful; trouble sleeping; tinnitus; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on Mar2021 16:00 (Batch/Lot Number: er8727), age at vaccination of 62-years-old, as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 10:00 (Batch/Lot Number: ew0151), age at vaccination of 62-years-old, as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing (mild asthma), drug hypersensitivity from an unknown date and unknown if ongoing (allergies: sulfa drugs), tinnitus from an unknown date and unknown if ongoing (mild tinnitus diagnosed 10 years ago), deafness from an unknown date and unknown if ongoing (diagnosed 10 years ago). The patient received tetanus vaccine in left arm on 12Mar2021 within 4 weeks prior to the COVID vaccine (age at vaccination of 62-years-old). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included pantoprazole (PANTOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported and hormone replace taken for an unspecified indication, start and stop date were not reported After the vaccine (both doses) tinnitus rose exponentially, and patient was diagnosed with hearing loss in both ears. Not sure when the additional hearing loss took place. The patient also become hypersensitive to sound, it was almost painful. The patient had trouble sleeping, listening to tv, music, going out to restaurants, etc because of this reaction. ENTs can only recommend hearing aids. After 9 weeks tinnitus has quieted a little bit but not back to pre vaccine level. The events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Treatments were given for the events (after first vaccine took a course of prednisone). Outcome for the events was unknown. Follow-up attempts are possible. Further information is expected.

Two weeks after Dose 2, given on 4-17-21, woke up with persistent muscle twitching in legs, somewhat migratory to upper body as well. This lasted from approx. 5 -9 AM, and receded as I started activity (or I didn't notice it.) This persisted for 2 weeks, every morning. Also, at this time developed clonic muscle jerks-- of legs, one hand curling, chest jumps, pelvic/lower abdominal bilat jerks, shoulder or arm jerks. This disturbed sleep on a couple occasions. Mild AM headaches for 2 weeks, and for last 3 days sharp R-sided head pains, scalp itching, and discomfort in the evening. Myoclonus seems better today after 3 days of taking NAC (N-acetyl cysteine) and herbs.

Stomach ache; Severe breast pain; I'm very tired still; She can't remember anything; Lethargic; Weakness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER8730 and Expiration date: Jul2021), via an unspecified route of administration in left arm on 29Mar2021 (age at vaccination 62-year-old) at 1st dose single dose for covid-19 immunisation. Patient Medical history included covid-19 from Nov2020 to an unknown date, tachycardia from Nov2020 and ongoing, postural orthostatic tachycardia syndrome from Nov2020 and ongoing, Brain fog from Nov2020 and ongoing. The patient's concomitant medications were not reported. Patient got Covid-19 infection on Nov2020. She said that she was a long hauler which means that she still has POTS (Postural Orthostatic Tachycardia Syndrome) and brain fog from COVID-19. She said that she has antibodies. Patient reported that she had been reading a lot of stuff and queried if it was ok for her to have gotten the Covid-19 vaccine after having Covid-19 in Nov2020. Patient inquired after being informed that she would be transferred Mortgage Insurers (MI) for her questions if she should wait to ask the other questions that she had as they were all medically related. agent offered to relay her questions to MI if a live agent was reached but Patient did not provide other questions. Patient reported that she had her first dose of the Covid-19 vaccine about an hour ago. Lot Number: Patient reported that she was pretty sure the lot number was ER8730 but stated that it could possibly be ERS730 as the 8 looked a bit like an S. Patient asked that why she still having these symptoms 2 weeks out after the vaccine. She had a stomach-ache and severe breast pain (the left side where I got the vaccine). It radiates into her left breast. When she leans over, it was severe to where she cannot touch her breast. The pain goes away, but it was random. She was very tired still. Patient asked that should she get the second dose. agents were busy during attempt to warm transfer. Thus, Adverse event E-transmitted. responded per CONS documents and provided disclaimer that Pfizer is unable to make recommendations for individual patients. Patient was asking if she has to start the series all over again if her second dose is delayed. Response: Responded per CONS document. Again, RN called as patient said that she called last week about the Pfizer COVID-19 vaccine that she took the first dose of on March 29th. She says she called today to provide more information, and to ask a question. She says after she took the first dose of the vaccine on the 29th she was still very tired, and her breast pain was worse. She says she has never had breast pain before, it was on the same side where she got the vaccine in her arm. She said her arm did not hurt, which she wondered about, but it went down into her breast lymph nodes, and her breast was hurting when she pushes it forward, she sits up or bends forward. She said it was hurtling so bad, and she was very tired, she does not know why it was taking two weeks. She said she was also still having brain fog. Patient said she cannot remember what she provided previously on her other report, she cannot remember anything. Patient said she had COVID in November2020 and now she had the vaccine and still can't get over it. Patient said that when she holds her breast forward, she feels the pain. She said she was very lethargic, and she had a stomach-ache until 28Mar2021 (yesterday) when she decided to drink Gatorade. She said she drank two bottles and the stomach-ache seemed to ease up. She said that the breast pain was frightening to her, it was a real sharp pain that was so bad that afterwards she can't touch until 5 seconds later. Patient says she wanted to know if she can still get her second dose in ten days and says that she doesn't know what the second dose will do to her if after the first dose it has taken two weeks to recover. Patient also mentioned that she had COVID-19 last Nov2020 and had tachycardia ever since. Patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine by the end of Mar2021 and had a bad Case narrative reaction (tachycardia, weakness, & fatigue). Patient is scheduled to receive the second dose on 26Apr2021. Patient asked that will she overdose (od) of antibodies. Patient already reported to Safety and confirmed. Checked the Pfizer-BioNTech COVID-19 EUA PI (LAB-1457-7.0, Revised: 06 rApr2021), mentioned no information found on possible antibody overdose, discussed Immunization Practices (IP) recommendation, gave disclaimers, and referred to health care professional (HCP) for guidance. The outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained. .

Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Severe, Systemic: Joint Pain-Medium, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Unable to Sleep-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Pt started experiencing syncope, chest pain, and neck pain on 5/31/2021. On the following Tuesday, she developed palpitation. On Wednesday, she was taken to ER by ambulance. At the time, she had rapid heart rate at 127 bpm. She was on IV fluid. On Friday, pt visited her cardiologist. She still experiences chest discomfort, lightheadness, and out of breath.

Massive migraine, nausea, whole body aches, chills, inability to sleep, painful injection site, lower back pain, chest pain, sweats. This was equal to or worse that when I had Covid during the winter.

The morning of February 21, 2021, I started having severe burning in my chest and in my back. It prevented me from sleeping without sitting up. I did not report to work for 3 days. I thought it was gastrointestinal since I already had covid in November 2020. After having another covid test on March 1, 2021, after being fully vaccinated, I tested positive for covid again. That prevented me from having a scheduled colonoscopy. I eventually had my routine colonoscopy on April 2, 2021 at the Clinic.

blood clot already eliminated; pain; This is really miserable because it persisting and it is always there; I feel like frustrated; light pink rashes in the back from knee above in both legs; both of my legs below the knees had really bad itches; mild pain in the back of the upper left leg; sharp pain at a spot in my left hip joint; Sore in the injection area; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 15:30 (Batch/Lot Number: EW0169; Expiration Date: 31Aug2021) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation, age at vaccination 62 years old. Patient is not pregnant at vaccination time. Medical history included diabetes mellitus from Sep2020 to and blood pressure (abnormal) from an unknown date. Concomitant medications included metformin taken for diabetes mellitus, start and stop date were not reported; dapagliflozin propanediol monohydrate (FARXIGA) taken for diabetes mellitus, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for blood pressure (abnormal), start and stop date were not reported. Clinical course was reported as follows: On 24Apr2021 noon (12:00), patient suddenly felt a shar at a spot in her left hip joint. It was then moved to the mild pain in the back of the upper left leg, which never disappeared. The pain there got a lot worse, so severe, also reported as now just a mild pain. Patient went to bed around 12 am on 25Apr2021, both legs below the knees had really bad itches; by next day 6 AM it was gone and never returned. On 26Apr2021, in late afternoon, in the back of both of the legs started bad it itches, and patient saw light pink rashes in the back from knee above in both legs, which disappeared by midnight, and never again noted. Sore in the injection area (Apr2021) similar to flu vaccine, which was gone after a few days. Patient stated adverse reaction getting worse and asked how it can be resolved because he can't function normally because of adverse effect. Patient stated that this is really miserable because it is persisting, and it is always there. He stated he is a normal person his breath, he still sees, still read, and is sound. He feels he is in constant pain, mild pain is annoying, but this week is so worse. Patient stated his "blood clot already eliminated" (onset date unspecified, event not clarified). Patient felt frustrated. Second dose was scheduled on 14May2021, but he didn't take it, he cancelled the second dose because of pain. Treatment was not given for the events (does not take medications). Outcome of the events "blood clot already eliminated" was recovered on an unspecified date, "both of my legs below the knees had really bad itches" was recovered on 26Apr2021, "light pink rashes in the back from knee above in both legs" and "Sore in the injection area" was recovered on Apr2021. Outcome of "sharp pain at a spot in left hip joint" and "mild pain in the back of the upper left leg" was not recovered (persisting for three weeks). Outcome of the other events was unknown. Seriousness reported as non-serious. Follow up needed, further information has been requested.

Itching of tongue, mouth, throat; Itching of tongue, mouth, throat; Itching of tongue, mouth, throat; lump in throat; 2 asthma flare-ups; face swollen; itching on face, head and around eyes; itching on face, head and around eyes; Occasional waves of feeling very warm; burning feeling around elbows; This is a spontaneous report from a contactable consumer reporting for herself. A 62-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm, on 07Mar2021 13:30, at 62 years of age, (Batch/Lot Number: EN6205) as single dose for COVID-19 immunization. Medical history included contrast media allergy, asthma, hypertension, hypothyroidism, glucose tolerance impaired (pre-diabetic) and allergy to erythromycin, cefaclor (CECLOR), penicillin, cefalexin (KEFLEX), neosporine, polysporin, sulfa drugs, eggs, tree nuts, peanuts, fish, shellfish, mushrooms, mustard, chocolate, some melons, raw apples (rashes of hives reactions). The patient didn't receive any other vaccine in the four weeks previous to COVID-19 vaccine. The patient received unspecified concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested from COVID-19 post vaccination. On 07Mar2021 at 13:45 the patient experienced itching of tongue, mouth and throat, sometimes lump in throat, 2 asthma flare-ups, face swollen, itching on face, head and around eyes, occasional waves of feeling very warm and burning feeling around elbows. The patient began treatment with famotidine (PEPCID) and diphenydramine hydrochloride (BENADRYL), contacted Doctor's office, then went to ER the day before this report. The physician assistant in ER prescribed 20 mg prednisone daily for 5 days. At the time of the report the reported events had not resolved yet. No follow-up attempts are possible. No further information is expected.

Chronic nonstop dizziness, burning head, brain fog, inability to walk any distance without feeling of drugged drunkenness. Off-balance. Onset three weeks after second vaccine, has been steady 24/7 since then.

had an anxiety attack/the anxiety attack was really out of the ordinary; had a horrible panic attack/having hot fiery panic attacks; bad taste in the mouth; couldn't sleep real well/she can fall asleep, but she cant stay asleep, she recalls on the first night after getting the vaccine, on 19Feb2021 she would wake up every hour; her hands are clammy, she is sweating; her hands are clammy, she is sweating; This is a spontaneous report from a contactable consumer (patient herself). A 62-year old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route of administration in the left arm on 19Feb2021 (Batch lot number EN6200) (at the age of 62-year old) at single dose for Covid-19 immunization and alprazolam (XANAX XR) orally at 2 mg in the morning at 6 AM and 1 mg at 1 PM (3 mg daily total) for anxiety. She actually had 2 separate prescriptions: one was a Xanax Extended Release 2 mg pill, and the other was a Xanax Extended Release 1mg pill. Relevant medical history included breast cancer from 2006, high blood pressure and cholesterol abnormal. Concomitant drugs included medication for high blood pressure and cholesterol medication. The patient reported that usually her anxiety was managed by medicine, however after the shot, Friday at noon, it was weird she had a horrible panic attack. She also had the panic attack Sunday, yesterday, and a little today. Her anxiety was always controlled prior to the first dose of vaccine but after the shot, it wass not, her anxiety was out of control. She noticed her anxiety incident probably Saturday morning around 6 AM. She did have complications on Friday 19Feb2021, it was a bad taste in the mouth and she couldn't sleep real well at night. She clarified that she can fall asleep, but she cant stay asleep, she recalled on the first night after getting the vaccine, on 19Feb2021 she would wake up every hour. Anxiety was not controlled: it would say being controlled by her medicine as far as intensity of the anxiety attack. On Saturday and Sunday was the biggest anxiety attack, and it was as if she was not even on the medication that's what it felt like, she was not better, the anxiety was still there. Like during the panic attack her hands were clammy, she was sweating, its an anxiety attack, it could be hormones. This was like as if she was not even taking her Xanax XR, she was having hot fiery panic attacks. She just had a physician appointment 2 weeks before the report (and before the vaccination) and everything was fine: "perfectly fine". The outcome of bad taste was recovering, the outcome of sleep unwell was not recovered while the outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.

significant fatigue; temperature was taken when waking up - 101F orally; she slept more; localized injection site pain and redness; localized injection site pain and redness; This is a spontaneous report from a contactable nurse (patient). This 63-year-old female Nurse reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular at right arm on 17Dec2020 08:30 PM at single dose for COVID-19 immunization. Facility type of vaccine was hospital. Medical history included shingles in Jun2020 after illness that mimicked COVID-19 but all tests came back negative - was sick for 3 weeks; no other chronic health conditions; severe beef/pork allergy - anaphylaxis. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medications were not reported. No other vaccine in four weeks. On 18Dec2020 02:00 PM, patient experienced significant fatigue; she slept for 1 hour and temperature was taken when waking up - 101F orally; she slept more; she had localized injection site pain and redness for 3-5 days. No treatment was received for events. It was reported as non-serious. Outcome of events was recovered in Dec2020.

HYPERtension, Syncope Hx. HTN and did not take BP meds in the morning. also anxious about immuniation. Narrative: History of recent stress test with pending results. pt. c/o lightheadedness while seated in recliner during observation. Per pt., she feels anxious after witnessing another person have a syncopal event. BP 240/98, P 76, R 22, O2 sat. 99% at 0935. RRT in the area so they assessed the pt. and convinced her to go to ED to be checked out. D/c'd per w/c to the ED with RRT. ED reported BP 190/108 in the ED. States she did not take BP meds in the morning and was anxious about her immunization today. ED reported she took her Losartan at 4pm. Discharged from the ED. Recorded on employee medical file on database.

20 mins after receiving vaccine, sensation of "wave" through brain with almost loss of consciousness. BP 151/93, 10 minutes later BP 130/83. Severe Dizziness and intense anxiety attacks commenced within 24 hours and lasted for 7-8 days. These were accompanied by sensation of pressure in brain and headache. Treatment with hydroxyzine 25mg once or twice a day reduced intensity of anxiety attacks but did nothing to help with the dizziness. Headaches were intermittent during this period. Almost all dizziness subsided by day 12 post vaccine. Headaches subsided by day 5.

I immediately felt dizzy, and there was ringing in my ears, I felt faint. I also felt shakey. I have had these symptoms for 12 days, unchanged. I cannot work because of these symptoms. I have been to urgent care and have had lab work and an EKG

severe achiness and shaking and fever to 104 F on 1/3/21. Unable to work for two days. Question is - should I get the #2 dose in light of the robust antibody response to #1. Could it be even worse?? Any information on this?

I felt ok right after the injection but about 2 hours later I started experiencing a pressure headache, gradually felt very poorly and took a nap for a few hours. Upon waking I felt ok but after walk; weakness; felt very poorly; This is a spontaneous report from a contactable other health care professional. A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL1284), intramuscular on 04Jan2021 11:45 at single dose at left arm for COVID-19 immunization. Medical history included hypothyroidism, psoriasis. Concomitant medications included etanercept (ENBREL), and levothyroxine. The patient felt okay right after the injection but about 2 hours later, on 04Jan2021 14:30, she started experiencing a pressure headache, gradually felt very poorly and took a nap for a few hours. Upon waking the patient felt okay but after walking around the house for about 20 minutes, the headache started up again and the same awful feeling of weakness so she laid down and took another 2 hours nap. When the patient woke up the second time she felt as though nothing had happened, was feeling fine. So the patient would say the side effects lasted for about 5 hours. The outcome of the events was recovered on 04Jan2021 17:00.

horrible body aches; Nausea; head fogginess; felt like a lump and couldn't move; not wanting to eat; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (Batch/lot number: E10140) first dose on 28Dec2020 11:15AM in the right arm at single dose since she is front line health care worker. Medical history included pain. Medical history included tramadol for pain. No Prior Vaccinations (within 4 weeks). Family Medical History Relevant to AE was none. She received the vaccine 28Dec2020 and it flattened her for two days. Her primary care provided has advised her not to take the next dose. Within 45 minutes she noticed nausea. She was eating lunch and she felt like everything was coming up and she forced herself not to vomit. The she noticed horrible body aches; head was foggy; she felt like a lump and couldn't move;. The body aches hurt in her arms, legs, hips, and back. Adds she was out of work for two days. She could feel it working as the symptoms would peak and then drop. She did go back to work but shouldn't have as she continued to feel nauseous and not wanting to eat. All of these symptoms have now resolved. Vaccination Facility Type was nursing home. No Vaccine Administered at Military Facility. Facility Name: Nursing Home. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Event not resulted in Physician office or ER. The outcome of the event nausea was recovered on 02Jan2021. The outcome of event not wanting to eat recovered on 03Jan2021. The outcome of other events was recovered on 01Jan2021. The seriousness criteria for event horrible body aches was reported as medical significant.; Sender's Comments: The patient had medical history included pain. A possible contribution role of the first dose of BNT162B2 to the horrible body aches cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

up a lot during the night after vaccination, lots of body ache, temp 100.2 dizziness during the day on 1/12

Initially muscle soreness at injection site. At 12 hours headache began. During the night body aches and restless sleep, bad dreams. Next day headache, significant fatigue and body aches. Emotional feelings like I wanted to fry ( I am not a crier). 2 Nd night restless sleep, bad dreams, headache. Next day brain fog and significant dizziness and vertigo.

Fever of 100.1, chills, body aches (Lower half of body only), headache, extreme fatigue. Missed work. Started at 4 am, about 18 hrs after vaccine given. Lasted 24 hrs.

Patient monitored for 15 min after her 2nd dose of vaccine and she experienced no symptoms before leaving the clinic. She returned 2 hours later with anxiety, hyperventilation and paresthesia. Vital signs showed improvement before symptoms resolved.

Chills-blankets and heater. 5 hours Headache-slept, 8 + hours fatigue-slept and felt run down 2 days

The following day after patient received 2nd dose of Pfizer vaccine, the area around the injection was light red, warm to touch and painful. The area was approximately 2.5 inches around. On Sunday 1/10 it was bright red, indurated, hot to the touch and much more painful. It was also painful to move his arm. On 1/13, the injection site was still tender to the touch and his shoulder area was sore with movement. Over the next couple of days his shoulder into his bicep had a dull ache and was very painful to any pushing, pulling or weight bearing. Ibuprofen did help but did not relieve it. On 1/17 patient went to a local urgent care because at that point it was even difficult to sleep due to pain. They diagnosed him with bursitis of the left shoulder due to SIRVA. He was started on a steroid pack and today, day 2 of steroids it feels slightly less painful.

respiratory distress; fever; anxiety developed requiring oxygen; Passed away; This is a spontaneous report via a Pfizer-sponsored program from a non-contactable consumer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included anaphylactic reaction (broad), neuroleptic malignant syndrome (broad), anticholinergic syndrome (broad), acute central respiratory depression (broad), hypersensitivity (broad), respiratory failure (narrow), drug reaction with eosinophilia and systemic symptoms (broad), hypoglycaemia (broad), COVID-19 (broad) and chronic obstructive pulmonary disease (COPD); all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium and lorazepam (ATIVAN). Within 24 hours of receiving the vaccine, the patient experienced fever, respiratory distress, and anxiety developed requiring oxygen, morphine and lorazepam (ATIVAN). The patient passed away on the evening of 26Dec2020. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: negative on an unspecified date. The outcome of the event death was fatal, while of the other events was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Passed a

Body aches, very sore injection site, tired feeling, nausea, slight headache. I had the chills, couldn?t get warm. Got worse during the night. Couldn?t go to work the next day due to body aches, arm soreness, extreme tiredness. Slept almost all day 1-19-21. Spiked low grade fever during the night. Worked 1-20-21, but extremely sleepy. Injection site got hot and red. Slept 12 hours that night. Went to work 1-21-21 feeling good, just still a little arm soreness.

Evening of both doses I had nausea which went away overnight, (also had very strange dreams with frequent waking up which might have had nothing to do with the vaccine). Second dose nausea the first night, extreme fatigue the second day which was gone by day 3. Headache from day after vaccine until today (5 days later) with more severe headache and dizziness today, but not bad enough to make me not be able to function.

Diarrhea and abdominal cramping 1 hour after second dose of Covid vaccine. Took OTC medication, Imodium, motrin, soft bland diet. Six + episodes of diarrhea in one hour on 1/21/2021 with significant cramping. Went to ER. Received fluids and IV Zofran. CBC and CMP WNL. Stool test also done--negative. Discharged. Severe diarrhea morning of 1/22/2021. Missed work on 1/21 and 1/22. Diarrhea and abdominal cramping continued intermittently. Worked Monday. Stool samples provided. C.Diff negative. Lactoferrin positive. Enteric bacterial panel negative. CT of abdomen scheduled for 1/27/2021

I noted onset of chronic, mild nausea 15Jan21 to present. Eating or drinking usually quells it. Bilateral ramped up to the point & noted that I am talk louder than usual and am asking 'What did you say?' frequently with hearing aids. Having to discriminate against tinnitus causes mental fatigue. Marked increase and violence of head tremor (as noted with influenza vaccine) making sleep difficult where head will not stop shaking.

Fever, chills, unaware of surrounding, delirium- time frame from approximately 11:15 am to 4:30pm . She was by herself, discovered after a phone call to check on her

428801 - Number given on Vaccination log - that day of the Vaccination dose 2. (Patient stated shortness of breath was another symptom that she had from COVID and is continuing somewhat especially when I was a mask for work - but had not put it in the first report). Chills on Friday morning in the middle of night; woke up and my temp was 101.3 and I was feeling bad all day; had headache and went back to bed. Still have pain in hip/knee and joints and those pains got really bad after the vaccine - increased. Doctor vist told me to use Ibuprofen to 3 times a day for that pain. Shortness of breath continues from Covid symptoms and so does the hip/joint pain - it has decreased.

About 5:30 or so and I was going to go to lunch at work - I felt like a heartburn and I was looking for a tums. I didn't have any. I asked a coworker because my chest felt like I had heartburn. It was really bad. Protonic - a coworker gave it to me to see if that would help. And I took it. Diaphoretic - sweating - coworker noticed that I was sweating. I had pain in my jaw. I thought I was showing signs of a heart attack. A doctor came over and we told her what was happening with me. He recommended that I should be seen right away. Next thing I know, nurse is wheeling me down to ER in wheelchair as my chest pains weren't going away but ER told me I had to go through triage and wait. Finally got seen and I had an EKG - which was good. CDU unit - was admitted to and checked Troponin levels and did blood work. Everything came back fine. My EKG was being monitored all night. At one point I was feeling something and they gave me a dose of Nitro. It gave me a headache. There all night and then I did a stress test in the morning. And I was released that day. That was my day off so I was off all work. I went back to the work the day after. My granddaughter came to stay with me over Christmas and she started having symptoms of COVID. She wasn't feeling well. /She tested positive.Symptoms for COVID began for me on December 26th and was tested for COVID on December 27th - cough; sore throat; headache, fever, not got chills or lose my taste or smell (until after those symptoms were finished); belching - lots; diarrhea; upset; nausea. Extremely tired and muscles aches, joint pain - settled in my lower back and my hip. I still struggle with those joint pain and tiredness today. They put me off work until January 12 2021. I was scheduled to get the dose 2 at 9th but didn't get it that day because of COVID illness.

8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest; tightness bilateral flank area; HA; body aches; diaphoresis; hot feeling; numbness tingling of head; numbness tingling of head/tingling in jaw and over the top of my head; pressure in the back of my neck; blurred vision; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in right arm on 14Jan2021 10:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. Medical history included HTN, GERD, constipation, ocular migraine, osteoarthritis in sacroiliac joints, small fiber neuropathy, glucose intolerance, steatotic liver, CTS (Carpal tunnel syndrome). Concomitant medication included losartan (LOSARTAN), furosemide sodium (LASIX [FUROSEMIDE SODIUM]), and spironolactone (SPIRONOL). The patient previously received the first dose of bnt162b2 on 24Dec2020 10:00 AM for COVID-19 immunization. On 14Jan2021 11:00, the patient experienced tightness in chest tin which the patient took benadryl 25 mg with improvement, tightness bilateral flank area, HA, body aches, diaphoresis, hot feeling, numbness tingling of head, pressure in the back of my neck, and blurred vision. On 15Jan2021, the patient had an 8/10 chest pain radiating into left arm subsided after 10 mins, tingling in jaw and over the top of head, chest tightness and tightness in both flanks most of day 2. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162B2 administration to the event chest pain cannot be excluded. The status of medical history including HTN, GERD, constipation, migraine and osteoarthritis in sacroiliac joints would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

starting on 1/19: headache; burning behind eyes and sore throat; x 3 days which have now resolved - now dizzy when standing; fatigue - arms feels heavy when taking shower; pale; remains very weak and tired; dizzy - feels like anemia - tried to work last night but broke out in cold sweat and pale so sent home from work last night - sxs are not worsening

Severe chills, painful glands especially under L arm, fever (low grade, never over 100.5), muscle aches and weakness, joint pain, severe head ache, nausea, extreme fatigue and slight confusion. Started about 11 hourse post injection and symptoms lasted 20 hours. Acetaminophen and increased water intake. Intermittent bedrest. Missed a day of work. Then suddenly everything cleared and I was wide awake and clear headed, just a little weak in muscles.

Muscle had severe burning sensation along with a peculiar feeling, like shards of glass embedded comes and goes but enough to interfere with daily living and movement

The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions and some tingling at the injection site about 30 minutes after vaccine. Around 9:00 pm I started feeling weak and muscle aches all over, so went to bed. Around 2:00 am on 1/31/21 I woke up in pain all over my body muscle ache, headache, and difficulty walking. Took temperature 99 and my average temp is 97.9. I took one extra strength Tylenol. On 01/31/21 I just felt bad all day felt like COVID symptoms but no breathing difficulties just bad headache all day, weakness, entire left side my body left arm, left side chest, left leg hurt worse than right side. I?ve just treated with extra strength Tylenol and rest. Last night temperature was still 99, but sleep through the night. Today, February 1 still weak, ache all over, mild headache, and some pain on my left side body. I have not sought emergency treatment as if the date/time of report. I?m a healthcare worker taking today and tomorrow off work to recover.

Driving home on the 28th she started feeling dizzy, shaky. She says she feels fine when she is lying down, but not when upright. She called her doctor and they told her to monitor her symptoms and call if she got worse.

Loss of taste; Tightening in the jaw; Tightening is on the side where the forehead is and the front like on the two sides is the pressure on the side of the head; just thinking of a headache; I have been feeling lot of fatigue; crying; This is a spontaneous report from a contactable consumer. This consumer reported for herself that the 63-year-old female patient received first dose of bnt162b2 (Unspecified Shot), via unknown route of administration on 15Jan2021 at single dose for covid-19 immunisation (to make sure because I am a caregiver). Medical history included Sjoegren's syndrome and had like chronic fatigue but "that is not a real thing". Concomitant medications included buspirone hydrochloride (BUSPAR) and other medications that she just take a half every other day, it is a small amount. She take 5 mg every other day. She was really taking much. The consumer had lab work, may be not sure 2 to 3 weeks, she has been feeling lot of fatigue. Actually, she did do lab work, it was just like lot of blood work. The consumer stated, "I am having some loss of taste and tightening in the jaw and that was immediately. Tightening is still there and the taste loss seems to happen like a day later. Tightening is on the side where the forehead is and the front like on the two sides is the pressure on the side of the head. I guess, just thinking of a headache. I guess, I had headache and crying, it is just nerve-racking." The events started from 15Jan2021 with outcome of not recovered. Treatment received included Advil. Information on the batch number/lot number has been requested.

delirious dreams; extreme chills; so cold that it felt like burning ice cubes on skin, could not get warm even with multiple blankets; severe body aches; severe headache; fever of 101; nausea; thirsty; Symptoms began to abate today (almost 48 hours later) but still fet some foggy thinking; This is a spontaneous report from a contactable other health care professional (patient) and a contactable consumer. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELIZ83), via an unspecified route of administration at arm left on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at arm left on 29Dec2020 at 9:30 at single dose for COVID-19 immunization. On Jan2021, the patient reported that 15 hours after second dose, he experienced extreme chills, so cold that it felt like burning ice cubes on his skin, he couldn't get warm even with multiple blankets, severe body aches, fever of 101 F, severe headache, delirious dreams, nausea, thirsty and feel some foggy thinking. The patient outcome of the event was recovering.

hives and rash on arm, patient was alarmed, went and hid in the kitchen, was concerned tablets wouldn't work so gave Benadryl 50mg

Soreness and swelling at site of injection 4 hrs after injection Chills one day after vaccine Joint pain one day after vaccine Fatigue one day after vaccine Foggy, light headed feeling one day after vaccine Headache and fatigue day 2 after vaccine

Dose 1 and 2 usual adverse events. Sore arm, achey, tired and crappy. But after dose 2 after 24 hours I began to notice itching. My back, neck, legs, arms. Begins once my zyrtec wears off around 7:30 pm I always take and antihistamine to keep my nose clear for better sleep. All nighttime meds are take at 8- 8:30 pm. Must take ativan to control anxiety and help get to sleep

Patient received 2nd dose of vaccine at 4:15pm. 15min later had left arm pain and numbness on the left side of body. She seemed very anxious and distressed. did not want labs or imaging, got anxiolytics and Tylenol and symptoms resolved in 30 minutes.----per MD

Fever to 101 beginning about 5 hours after injection. Followed that evening by nausea. Fever and nausea persisted all night. Sat AM 1/30/2021 fever had broken, nausea persisted. After a couple sips of tea, returned up stairs to go back to bed: Sudden complete loss of consciousness (syncope), striking right forehead on wooden chair as falling to the floor. Completely unresponsive for 5-10 minutes. Then confused but responsive to voice. Amnesia for events for at least the next hour. Taken via ambulance to ER for evaluation. Trouble with concentration and dexterity for nearly a week. Bruising and tender forehead for more than a week. Left arm injection site became red and itchy 1/31/21, for several days.

Chills, fever (100.7), bad headache, weakness, queasy stomach, vomiting (1x), lack of appetite. Fever broke after 2 days, headache lasted 3 days, weakness remained for 5 days, strength improved more each day after that. Returned to work 7 days after vaccination. Appetite returned slowly after 2 days of little to no eating, seems to have normalized now at 2 weeks since vaccination.

Muscle ache; Chills; Fever; was cold; Joint ache; Tired; Sick; could not sleep all night, she was up half the night; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: F19262), via an unspecified route of administration at her arm on 23Jan2021 at 0.3 mg (as reported) single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that that she and her 94 year old mother got the COVID-19 vaccine at a drive thru, and her mother did great. After the vaccine she had muscle aches, chills, fever, and was cold. She had side effects that lasted 30 hours, starting that night. She was chilling so bad, she would like to know if they think it was safe for her to get the second dose of the vaccine, they said it was worse for the second. She said she could not hardly work she was so sick after the first dose. She stated that she was really cold, and really sick, and all day, she just could not sleep all night, she was up half the night because she was so cold and just feeling sick. She had joint pain, she had it all. She started taking Aleve on Sunday and she started to get better. The night after she got the vaccine she got her heater and was sitting beside it. She felt tired the whole next day. Her symptoms came quicker than that, she took the Aleve the next day. The outcome of events muscle aches, chills, fever, joint ache was recovered. The outcome of other events was unknown.

Extreme tiredness; blurred vision and mental fog; heaviness in the chest; difficulty breathing; mild headache; pain in my toes feeling like they were broken; chills; sweating. Lasted from 3-7 pm although 4-7 I was in a sound sleep but aware of the symptoms I was feeling. It was a very unusual feeling of unconscious then conscious delirium feeling.

strange feeling and some pain began on left side of neck, left ear and went up my whole neck to my face. Unsure what the feeling was then realized it felt numb and swollen. tongue felt thick. kinda of like after being numb at dentist office. I also felt kind of tired. I was afraid my throat was going to close up but it didn't. after 1 hour the feeling began to fade. and then went away.

Report from assisted living. starting 2-15-2021 Client was confused. UTI ruled out. She was wandering places she should not. She was in another residents room. She is speaking to staff in another language. VERY confused. Trying to eat her napkin. Unable to dress herself. 2-16-2021 incontinent. not normal for her. unable to stand up. very weak. still very confused. left arm pain. falling asleep mid sentence.

My body was stiff and sore all over, for about 3 days ran fever 100.7 couldnt go to work 24 hours , and chest pains for 5 days and unable to lay on side while sleeping chest was enflamed, shortness of breath

tongue was swollen and swore feeling in the back of mouth/tongue sensation continued with swollen feeling; tongue was swollen and sore feeling in the back of mouth/tongue sensation continued with swollen feeling; difficulty swallowing; sore throat sensation; no appetite; severe abdominal pains; diarrhea; mild heart palpitations; developed fever of 101 Fahrenheit; chills; back pain; Could not Sleep; This is a spontaneous report from a non-contactable consumer reported for herself. A 63-year-old female patient (not pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3247, via an unspecified route of administration on 22Jan2021 09:00 at single dose in left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was in hospital. Medical history included Hashimoto Disease; Moderate Metro Valve Prolapse; known allergies: food Intolerances (Gluten, Eggs, Diary, Soy, Corn). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ciclosporin (RESTASIS), calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D), ascorbic acid (VITAMIN C), ubidecarenone (COQ-10). The patient previously received the first dose of bnt162b2 with lot number: L0140 on 30Dec2020 10:30 AM in left arm for covid-19 immunisation, ciprofloxacin (CIPRO) and experienced drug allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 (Friday Evening) post injection, she could not sleep. On 23Jan2021 (Saturday) severe abdominal pains post breakfast; breakfast was gluten free bread with vegan scrambled eggs and coffee w/ oat milk. Continued diarrhea for about 1 hour; mild heart palpitations, developed fever of 101 Fahrenheit; mild chills and back pain. On 24Jan2021 (Sunday) - still with fever 99.8; no appetite. On 25Jan2021 (Monday) - tongue was swollen and sore feeling in the back of mouth; difficulty swallowing; sore throat sensation; pain of swelling caused it hard anything; remained home from work, did not see medical doctor. From 25Jan2021 to 28Jan2021 tongue sensation continued with swollen feeling, each day getting slightly better by 28Jan2021 (Thursday) feeling normal. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered in Jan2021. The reporter considered the case as non-serious. No follow-up attempts are possible. No further information is expected.

This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 01:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included benazepril, atorvastatin calcium (LIPITOR), and ubidecarenone (COQ 10). On 02Feb2021 01:15, after 5 minutes getting the vaccine on her left arm, it started to get numb and her back and left leg. She had a headache and nausea. The nurse at the clinic took her to a room to rest and applied ice pack on her left arm. She stayed in the room for 2 hours. At night, her heart rate was rapid and she could not sleep. Next day, she had muscles sore and headache. Therapeutic measure was taken as a result of numbness in the left arm,. No treatment was received for the other events. Clinical outcome of the events was recovered with sequelae. Information on the lot/batch number has been requested.

Within 1.5 hours of vaccine #1: Eye pain (both), itching without visible rash (left buttock only), thumb pain, brief leg "heaviness" (both) and fatigue, brief RLQ pain, increased tinnitus. The next evening: low back and neck (bone?) pain while attempting to sleep, out of character to usual back pain. By day 3 post injection, left nose tingling similar to onset of cold sore, which included left side of mouth the next day. By 7 days post injection, entire mouth area felt tingly similar to Novocaine wearing off. This lasted 3 days. Now improved. (took B-12 p.o.) Other brief episodes of chest discomfort, gum irritation, and anxiety. Vaccine #2 scheduled for 2/19/2021

Pt complained of throat tightness and being lightheaded beginning at 1127 hours (5 minutes after vaccine). She arrived at emergency/symptoms reporting station at 1129 hours. She denied tongue swelling, denied rash, denied difficulty speaking. No rash was seen by medics either. Pt did not have wheezing or stridor. Medics on scene and student medics under the direction of Medics, placed the patient on the monitor. Her HR was stable in the 70s and her sats were 99-100% on room air, with a strong pulse and RR of 16. The pt became more anxious and demanded that someone assist her with her Epi pen administration. RN explained sxs of anxiety and sxs of anaphylaxis. Pt became agitated and again remained adamant that medics give her Epi. At 1132 hours a student medic under the direction of Medics administered the pts own epi pen to her. Vitals signs after epi were HR of 88, BP of 170/97, RR 22, sats 100% . A transport unit was called as precaution and to potentially transport. Pt appeared to have an increase in agitation as indicated by her speech with medics being short and her stating that she was "irritated" with "everyone talking", that she "can't hear everyone all at the same time", that this is just "too much" and waving her hands in the air. Pt was transported to the ER via Medics for continued care and follow up.

I had a minimally sore injection sight the morning I had the vaccine. As the day went on I began to feel joint pain in my back. Around 2:00pm I began to feel chills. Around 5:00pm I registered a temperature of 99.1. My usual temperature is 96.7. I then had trouble staying asleep, had intense joint pain in my back, hands, and feet, which I treated with Tylenol around 11:00pm. I experienced heavy night sweats where I woke up at 5:15 am being soaked. The symptoms I felt overnight felt just like what I had when I was sick with Covid 19 in December 2020. My temperature had returned to normal by 6:00 am.

anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning sensation in her whole torso; fast heart rate; This is a spontaneous report from a contactable consumer reported for self and a contactable consumer (husband). This 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 09:00 on Arm left via Intramuscular at single dose (Lot # EL3247) for covid-19 immunisation. Medical history included allergic to penicillin when she was a kid. She said that her lips swelled up. No other products. Since receiving the vaccine, she's had a burnt taste in her mouth on 20Jan2021 and also reported that she had a burning sensation in her whole torso that lasted 2-3 mins after she received vaccine on 20Jan2021 and her heart rate was racing but resolved after a few minutes. She had a metallic taste in her mouth. It made her very anxious and she was having a fast heart rate on 20Jan2021. She got panicky because of the metallic taste. She clarified that the burning sensation she felt was a burning in her whole torso on 20Jan2021 and it was extremely hot like a chemical went into her body that was burning her guts. She said that the burning sensation only lasted 2-3 minutes and was gone. She said that she got scared and her heart was racing a little bit on 20Jan2021. Her heart racing resolved that same day after a little bit. She clarified that she has like a burnt taste in her mouth. She said that it is the roof of her mouth and her tongue that taste like this. The burnt taste is still ongoing. She said that she tried to call the physician, but has not heard back yet. She said that she had chills and no appetite that day on 20Jan2021, but it was gone by the next day 21Jan2021. Outcome of the event metallic taste in her mouth/ had a burnt taste in her mouth was not recovered. Outcome of the event burning sensation, fast heart rate was recovered on 20Jan2021. Outcome of the events chills and no appetite was recovered on 21Jan2021. Outcome of other event was unknown.

got dizzy; felt queasy; Temp was lightly elevated; Sore injection site; Could not sleep, very uncomfortable.; Got hot and sweaty about 3 1/2 hours after shot.; Got hot and sweaty about 3 1/2 hours after shot.; administration_date=26Jan2021; other vaccine date = 26Jan2021; administration_date=26Jan2021; other vaccine date = 26Jan2021; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unknown route of administration on left arm (L shoulder/Arm) on 26Jan2021 at 09:00 AM at the age of 63 years old at a single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included RA (Rheumatoid arthritis), Penicillin allergy and covid-19 (The patient was diagnosed with COVID-19 prior to vaccination). Concomitant medications included leflunomide (ARAVA) at 20mg, once a day, daily vitamins and mesalamine 1/day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Also reported administration date 26Jan2021; other vaccine date 26Jan2021. On 26Jan2021 09:00, the patient experienced sore injection site (shot was given very high on L shoulder/Arm). Felt like a sharp pain when given. Got hot and sweaty about 3 and an half hours after shot. Could not sleep, very uncomfortable. Next morning (on 27Jan2021), the patient was getting ready to eat breakfast and got dizzy and felt queasy. Temp was lightly elevated. Taking Tylenol to help control soreness. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events administration_date=26Jan2021; other vaccine date = 26Jan2021 was unknown and patient was recovering from all other events. Information on the lot/batch number has been requested.

Starting a couple hours after vaccination, I began to feel unwell, overall poorly, nothing specific. Went to be early at 9:30 and awoke at one a.m.on February 26 with splitting headache. Could not get back to sleep well and felt terrible all that day with headache, nausea, and foggy thinking, not funcional after about 2:30 p.m. Took Ibuprofen at 3 p.m., called doctor and went to ER at Medical Center. Was seen at ER a few hours later. Slept some in waiting room. Had sore throat, the worst splitting migraine type headache ever, and was extremely foggy headed, couldn't process thoughts, eyes had difficulty focusing, nausea. My temperature was a little high for me, I am normally low and it was 99. My blood pressure is usually low and it was 105/59, pulse was 82 and respiration was 16 with 96 % Oxygen Saturation. They did tests and had an ophthalmoligist give me an exam also. They said I could go home with the same meds they were giving me in the hospital since they were working to alleviate my painful headache, 600 mg of ibuprofen, reglan and benadryl. Before I left they gave me the potassium chloride. I am continuing my medications today, two days after my vaccine.

2/28 6pm face flushed and puffy 10pm anxiety on guard, trouble sleeping 3/1 6am heart rate 108, no temp scratchy throat 10am diarrhea ; unease and rapid heart rate continue 5pm read about adverse events, called doctor, took Benadryl and began to feel better. 3/2 am communicated with doctor and she advised holding off on second shot, next steps tbd

Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at injection site. She reports feeling like a foreign body in injection site and reports feelings of tightness, pressure, and heat at site. Patient developed swelling of right arm over the next 3 weeks. Patient saw her PCP on 2/12/21 and an ultrasound was done to R arm. Results were negative. Five to six weeks post vaccine administration, patient is reporting weight loss over 10 pounds, possible hair loss, loose stools, and sweaty palms and feet. She also reports the right arm pressure and tightness is now radiating to her upper back.

Pt received 1st dose of Pfizer Biontech vaccine. Patient reported history of anaphylactic reactions. Pt told to stay 30 minutes for observation. During observation patient reported feeling itchy. VS taken at clinic and were stable: HR 88, BP 135/66 Spo2 94%. Patient's face was slightly red without edema. She reported breathing okay but felt a little tight in her throat. Sent to ER for management. Per ER note "63 year old female with a complex medical history including lupus, scoliosis, Sjorgen's syndrome, and anaphylaxis requiring intubation presents complaining of itching and dizziness following COVID 19 vaccination with the Pfizer mRNA vaccine...patient's exam demonstrates itchy red welts consistent with urticaria and she endorses a foreign body sensation in her throat. Examination of the oropharynx demonstrates uvular edema without stridor. The patient endorses chest tightness but does not have wheeze on exam...endorses nausea. Diagnosed with anaphylactic reaction. Patient received epinephrine 0.3 mg IM, diphenhydramine 50 mg IV, famotidine 20 mg IV, and methylprednisolone 125 mg IV along with albuterol MDI. Had improvement in symptoms within an hour, observed for 6 hours without recurrence of symptoms and was discharged home. Advised not to receive second dose of vaccine until discussion with allergist occurred.

HAD WAVES OF NAUSEA STARTING ON THURSDAY FEBRUARY 25TH ,THEN NAUSEA EVER SINCE ,NOW WHEN I GO TO BED I WAKE UP WITH NAUSEA. HAD VIRTUAL VISIT WITH DOCTOR AND SHE PRESCIBED SOME ANTI NAUSEA MEDS AND THIS MORNING WENT TO ER,PRESCRIBED MORE ANTI NAUSEA MEDS . . NOT SLEEPING BECAUSE OF THE NAUSEA. HAVE PC APPOINTMENT TOMORROW .

As expected, I was sore after the first injection, but waited until bedtime to take Tylenol. I did that in order to sleep better. I did have a lot of stool prior to bedtime, but didn?t think much of it, as I had a lot of water, and thought it might be due to nerves and eating a larger dinner than typical. I went to work, had lunch, and shortly after had explosive diarrhea. I went to clock out, felt weak, and had another episode. I took immodium so I could drive home, had 2 more bouts, took one more immodium, and have not had more. I do feel tender, but am not running a fever. I presume this is not related to the vaccine, but was advised to let you know.

I started to get a headache around 6:30 - by 9:30 the whole right side of my head felt as if it had a knife going from the base of my skull though my eye out the top of my skull. I was up most of the night with the most severe head pain that I think I've ever experienced. My husband stayed up most of the night with meI had taken 2 Tylenol and a muscle relaxer-Ophedrine? It did nothing for the pain. -I finally fell asleep around 5am and woke at around 7am. The head pain was gone. I had another duller headache the next night but not bad. Also had nasal drip and a few chills but that didn't last long. ( I think I might've had Covid in Feb 2020-I was sick for 4 weeks with strange symptoms that ranged from headaches, extreme nasal drip, dry cough, exhaustion, 3 days of inability to taste food but no fever)

Dry mouth, anxiety, tongue swelling, flushing/sweating. BP 160/84, pulse 111. Took Benadryl 50 mg PO.

While waiting in the lot, patient stated she experienced sensation of heart racing, slight SOB, mild anxiety. Monitor called RNS and NP. Patient reported to them that s/s were resolving. Vital Signs were monitored. B/P 100/78, HR 72. RN stayed with patient for 20 minutes. Patient ambulated steadily. Denied further s/s. Left lot at approximately 1300. B/P 108/70, HR 72 Respirations 18. Instructed to continue to monitor and to seek medical attention if symptoms return. RN called patient ! 1435. Patient reported no further s/s. Also mentioned that sehhad hypothyroidism and that synthroid dose had been decreased within that past week.

Sore left arm, sleeplessness 10:30 pm to 5:00 am 3/12-3/13. Took 2 Somnapure natural sleep pills at 11 pm 3/12 and Soothsayer herbal tea at 7 am 3/13. Very tired both shoulders hurt noon 3/13. Took an hour and a half nap from 1-2:30 pm 3/13. Still tired

Monitored pt as she was "worked up" about her husband who was being monitored as well post vaccine administration. vital at 0930, 175/88, 107, 16, 99% on RA. Pt refused any further treatment or monitoring and went home via ambulation w/ her husband at 0935

Patient started to have mild queasiness about 20 minutes after vaccine was given. Within a few minutes of the queasiness, patient started to feel dizzy and nauseous. Patient endorsed feeling "not quite right". Patient was brought over to paramedics for further observation. VS taken over the course of ~1 hour prior to patient being transferred to ED. Transport occurred on date of vaccination. On post-vaccine Day #1, pt continued to endorse some dizziness. Also noted to have SOB, headache, and mild body aches with a brief episode of chills. On post-vaccine Day #2, pt still felt SOB, more upon exertion. Pt had to use rescue inhaler every 4 hours, which helped pt "breathe and relax a little bit."

At time of vaccine administration, patient experienced a metallic taste in her mouth as she has in the past with other medications. Approximately 5-10 minutes after the vaccine, she felt a "prickly" feeling starting at the head moving down to the arms and down to her trunk. It was most prominent in her hands. Patient denies any shortness of breath, swelling, rash, or any other respiratory issues. Patient was monitored for 30 minutes after vaccine administration and "prickly" symptoms persisted.

Patient received Pfizer vaccine on 3/14/21 at 15:29, she was observed for 30 minutes was feeling fine and left. She returned to the clinic an hour (or so later) reporting feeling flushed and "off". We had patient sit back down and began observing again. Patient developed a cough which became progressively worse. We monitored her O2 sat, pulse and BP. At 3:30pm Patient received epinephrine 0.5mg IM and Diphenhydramine 50mg IM. EMS was called. Patient's cough subsided. She refused transport to the hospital AMA. Patient left the clinic on her own, accompanied by her husband. ;"

I started to experience a problem with my left eye about 6 hours after I received the vaccine. I could see small bolts of white light is the far outside corner of my eye. I first attributed it to an ocular migraine, but those usually only last maybe an hour. The next morning I could still see the bolts of light which were very distracting. I called in sick to work and went to see an eye doctor. He diagnosed me with a PVD (posterior vitreous detachment). It may have been coincidental, however since it occurred on the same day I received the first vaccine, I was advised to report it by V-safe who was doing periodic follow up through texts.

Both upper arms and upper back have extreme burning pain and tightness. All of my muscles ache. Both calves felt weak. Extreme fatigue. Increased ear ringing. Sinus and head pressure. Slight queasiness. When the shot was first given, I had immediate pain at the injection site and up my neck. As the day progressed I felt tired, achy all over. The burning, stinging pain increased, in both arms and upper back. It seems worse at night and wakes me up. It is severe enough that it makes me cry. I have used regular strength Tylenol, Regular strength Advil and Allegra, as treatment. The burning pain continues. So does the muscle aching and fatigue.

Fever; Chills; Achiness; nausea; flu-like symptoms; waking up over night; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), on Left upper arm via an unspecified route of administration on 27Jan2021 2:30/3 PM at single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient previously took first dose (lot number: EJ1685, EXP: 31Mar2021) at 4:30 PM for covid-19 immunisation. Caller says she got this number from the pamphlet that was given to her when she gotten her first dose of the Pfizer COVID Vaccine. She got the second dose yesterday. Early this morning (around 2 or 3 AM this morning 28Jan2021) in the middle of the night she started having flu-like symptoms. She was calling to make sure to report them and she wanted to know if it was okay to take Tylenol. She cannot remember if the people who gave her the vaccine said if she could take Tylenol if she needs it. She had a fever this morning of 100.6. She also has chills and achiness. She volunteers at a healthcare facility, which is where she got the vaccine. She will call them about it. Got the second dose yesterday 27Jan2021. She kept waking up overnight and could not get warm. She just was unable to get warm. It was early this morning. She had went to be around 11:30 PM and felt perfectly fine. She tried to drink OJ and keeps trying to drink lots of water. She ate some protein, some cheese. She was concerned not to eat because she did not want to counter balance the nausea and it get worse. She had a tinge of nausea this morning. Outcome of the events nausea and flu-like symptoms was unknown, Outcome of the event waking up over night was recovering. Outcome of the other events was not recovered. Information on the Lot/Batch number has been requested

I felt fine immediately after the injection, but then about 3 minutes after the injection, I was "hit" by a very intense reaction: metallic taste in mouth, nauseous, burning heat throughout my back, sweating, very hot, very anxious/scared. This quieted down after about 10 minutes, but then I got "hit" again, a few minutes after that. This time with burning heat in my chest and then burning heat traveling down my left arm, sweating, very hot, very anxious/scared. I was under observation for 45minutes before they let me drive home (just 4 miles away). Once I got home, I felt extremely exhausted and foggy headed. This lasted for about 6 hours, and then it began to lift. That night, I was woken from sleep suddenly by pain in my arm (at injection site); it was a sort of pain I've never experienced -- it was sharp and moving around. The following day (today) I'm having lingering fatigue, lingering slight nausea, and a sore arm at injection site.

I had a migraine the day after the vaccine, then on Wednesday, I had knee pain. I took steroids that night but I couldn't hardly slee because of the pain. I had to call out because I could hardly walk. Steroid dose was for 9 days and after wards it resolved.

Patient received the COVID 19 vaccine (Pfizer) at 1700. She became anxious. Nurses lied her down on a cot where she had a vasovagal response with loss of consciousness. Pt was disoriented x 2minutes. VS: BP 124/80, HR 86, O2 sat 100% room air, RR 18. Paramedics were called to evaluate patient. She was medically cleared by paramedics. Pt had a friend drive her home. Pt was stable when leaving.

When I first got it, I felt okay, but as I was walking out, I felt disoriented and had to sit down. I was very lightheaded and uneasy. I stayed about an hour because I was scared to drive. I later got chills and fever for about 24 hours. I eventually developed shortness of breath, headaches, dizziness, tightness in my throat, bruising in my legs and painful lymph nodes in my neck and arms. One day, I felt like I was having a mini-stroke. It only lasted for a brief period and then went away. That has occurred multiple times. My doctor thinks some of my issues were due to anxiety, but I don't agree because I'm fine now.

Patient had Pfizer vaccine 1st dose on Tuesday AM . Later that night, starting into Wednesday morning started to feel terrible - sore arm, headache, severe body aches, fever, chills, nausea. Continued through to Thursday. Pt started to feel intermittent SOB, difficulty with getting in air. This subsided after some time. NO rash, hives, tight airway, vomiting. Patient reports today feels a little better but entire body still has burning sensation. Going to Urgent care for evaluation.

Pt received vaccine at 1231 and within 10 minutes reported feeling "shaky" with a warm tingling feeling all over. She was moved via wheelchair to an observation area. Initial vitals at 1245 98% on room air, 100 HR, BP 157/94. Pt stated she was feeling better and was then escorted at 1330 to the bathroom via wheelchair. Upon her return, she reported now experiencing chills and was shaky. Vitals at 1340 were 176/86, 96%, and HR 99. Pt denied SOB, fullness in mouth, and itchiness. Further vitals: 1357 175/85, 96%, HR94. 1405 183/105, HR 107, 97%.; 1406 173/80, HR 104, 97%. It was determined by RN that 911 would should be called to further evaluate the patient. Patient was taken via EMS to the hospital with her husband in attendance.

Lip tingling, SOB for few seconds that resolved prior to my evaluation, feeling jittery/anxious. Vitals taking, pt reassured, symptoms resolved within minutes

Shortly after sitting down after vaccination, felt as body was exploding, either from sudden drop or sudden rise in blood pressure. Then severe vertigo set in, everything started spinning and nausea set in. Waited for 30 minutes and vertigo was better, but not totally gone, but nausea was still there. Left facility and nausea abated after 1.5 hours. Vertigo continued for 48 hours but fairly mild. Caused me to walk like a drunk person but no dizziness any more. Then at 10:30 PM torso broke out in hives that lasted about one hour. No hives on arms and legs.

Brain fog (forgetfulness, wondering what I needed to do), unsteadiness when walking and on stairs; normally walk quickly and on stairs, vision was off a bit more. Reactions started 12 hrs. after receiving shot and the 2nd day. 3rd day was fine.

This is my second report, I had received my 2nd Pfizer vaccine on 2/23/2021.On 2/24/2021I was a little achy and that night felt a little nauseous On 2/25/2021 I began to experience strange waves of nausea during the day. . that night I continued with the nausea and for the next few days had stomach issues. then that Sunday night i woke up with strange nausea and discomfort .I was having this every night Some days I would be fine and others would feel little queasy on and off. I ended up at the ER on Monday March 8th ,they ran blood and urinalysis and no other tests . They told me the nausea would go away. I have been to my GP twice and one virtual visit . I have been on pepcid , zofran which didn't help .and now prozac and xanax at night . I may have one night that is good and then the nausea will return. I was not sleeping or eating and was getting anxiety from the nausea. My doctor thought it was a side effect from the vaccine and the ER doctor said its so new they just didn't know. This is week 4 now and I am headed to a gastroenterologist this week . I am a healthy 63 year old with no underlying health problems . I have had stomach aches and nausea before but this is definitely different.

Client verbalized feeling anxious before/after receiving the vaccine. Client was evaluated by onsite Sheriff Fire Rescue. Client was released to go home at 12:17 pm after symptom was resolved per Fire Rescue.

Saturday morning I woke up feeling fine. About an hour later I had a bad headache and my body started to be achy. That was followed by bilateral eye pain so that the only comfortable thing to do was to put on eye shades. I was exhausted by the afternoon. I had absolutely zero energy to do anything but lie down. By Sunday morning every inch of my skin was sensitive, every joint was sore and every muscle group in my body was painful. The symptoms from the previous day remained; head and eye pain. I used both tylenol and advil a few times but without relief. Monday my body/joints were still achy and I was super tired but not like the previous 2 days. I became very depressed and fearful that it would not let up. Today is Wednesday and its the first day I feel like myself again although I did have to take a nap 3 hours after I woke up today. Body still aches but nothing like it was

Severe headaches, tiredness, fatigue, difficulty walking w/o assistance, lightheadedness, hallucinations that disappeared 3 nights after the vaccination.

Feverish, sweating, mid- level headache, and at 8 pm muscle pain especially in breasts, jaws and every joint that has arthritis was very painful. Couldn?t sleep until 3 a.m... Woke up at 5 a.m. and all symptoms were gone. None since.

Began feeling very tired and slightly confused. Left work one hour, one home I had a slight fever of 99 so I took Tylenol and tried to sleep. Woke with a headache and cold not get warm all night.

Pale and shaky; Pale and shaky; Blood pressure bottomed out; Heart was racing, her heart was beating really hard/pounding chest; Weakness; Fast heartbeat/Pounding chest; Lightheadedness; Insomnia; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 10Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient reported). A 63-year-old female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 at unspecified route in left arm on 08Mar2021 11:30 as a single dose (at the age of 63 years) at for COVID-19 immunisation. Medical history included iodine allergy from an unknown date and unknown if ongoing severe allergy , drug hypersensitivity from an unknown date and unknown if ongoing severe allergy , dysphagia from an unknown date and unknown if ongoing , ongoing Sjogren's syndrome diagnosed 33 years ago , ongoing systemic lupus erythematosus diagnosed 3 years ago , ongoing headache , ongoing intervertebral disc degeneration diagnosed with this about 15 years ago , ongoing fibromyalgia diagnosed 10 years ago , Meniere's disease from an unknown date and unknown if ongoing , supplementation therapy from an unknown date and unknown if ongoing Vitamin c (Verbatim): recommended by dentist bone health and teeth. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for supplementation therapy from 2020 and ongoing; vitamin d3 (VITAMIN D3) taken for hypovitaminosis from 2019 and ongoing; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for hypovitaminosis from Apr2020 and ongoing; timolol (TIMOLOL) taken for glaucoma from 2011 and ongoing; alprazolam (XANAX) taken for anxiety from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for dyspepsia from an unspecified start date and ongoing; cyclobenzaprine hydrochloride (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) taken for fibromyalgia from an unspecified start date and ongoing; cetirizine hydrochloride (GENERIC ZYRTEC) taken for hypersensitivity from 2011 and ongoing; atorvastatin (ATORVASTATIN) taken for blood cholesterol from an unspecified start date and ongoing; olanzapine (OLANZAPINE) taken for bipolar disorder from an unspecified start date and ongoing; docusate sodium (COLACE) taken for constipation from an unspecified start date and ongoing; lactulose (GENERLAC) taken for constipation from 2018 and ongoing; acetaminophen (TYLENOL GENERIC) taken for headache, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication from an unspecified start date and ongoing; tramadol (TRAMADOL) taken for intervertebral disc degeneration, headache from Dec2020 and ongoing; triamcinolone diacetate (TRIAMCINOLONE [TRIAMCINOLONE DIACETATE]) taken for rash from 2018 and ongoing; meclizine hydrochloride (MECLIZINE HYDROCHLORIDE) taken for dizziness, start and stop date were not reported. The patient experienced heart was racing, her heart was beating really hard/pounding chest on 08Mar2021 with outcome of recovered , pale and shaky on 09Mar2021 with outcome of recovered weakness on 08Mar2021 with outcome of recovered , fast heartbeat/pounding chest on 08Mar2021 with outcome of recovered , lightheadedness on 08Mar2021 with outcome of recovered , insomnia on 08Mar2021 with outcome of unknown , blood pressure bottomed out on 09Mar2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 'bottomed out' on unspecified date 09Mar2021, heart rate: 95, heart rate: 98-101, heart rate: fast. Therapeutic measures were taken as a result of , insomnia. No vaccines administered on same date with the Pfizer vaccine. No vaccinations within four weeks prior to the first administration date. No ER visit or physician office visit reported.

fever/chills/body aches/ painful arm/shoulder injection site feels like stabbed with knife can barely move it or sleep on it, tired feels like a mild flu

same day patient devloped sever shoulder pain in vaccinated arm, chills, fatigue and cough, She was unable to work the follwoing 2 days due to severity oif her symptoms. She also reports a mild rash at injection site.

I began to experience very painful nerve pain in my body, most noticeable in my feet area making it painful to walk. I had been exercising and after the Pfizer covid vaccine shot, it hurt too much to exercise.

Throat swelling, tongue tingling Narrative: Code 99 called to the second floor auditorium where this simply received her second coronavirus vaccine. Approximate 10 minutes later she developed tightness around her neck and her tongue started to swell. No chest pain or shortness of breath. No rash. Didn't have a problem with her first vaccine. Epinephrine 0.3 mg 1M and Benadryl 50 mg 1M given. The patient started to feel better. Tip of the tongue was slightly swollen and red. Patient spoke in normal sentences. No stridor. Appears well and resting completely in the wheelchair. Brought to the emergency department for further evaluation and observation. ED provider note: 62 yo FEMALE w/ Wo multiple medication allergies p/w possible allergic reaction. Pt recieved her second covid vaccination today @ approxately 1330 and reports nearly inmediate onset of sensation of "like a pill is stuck in your flu-oat" and feeling like her throat was swelling. Then states that she developed an abnormal sensation on the tip of her tongue described as tingling and swelling. Denies any n/v, abdominal pain, sob or difficulty breathing. Pt received 0.3 mg of 1M epi as well as 50 mg of 1M benadryl. Pt observed in ED for 6hrs,She was given steroids and Pepcid in the ER. She has an EpiPen at home due to an allergy to bee stings. I told her that while a recurrence of her reaction is she should pay close attention to any new or worsening symptoms and return to the ER immediately for chest pain, shortness of breath, oral swelling, GI symptoms, or any other new symptoms she develops that she is concerned about. She expressed understanding of this plan. She was given a short course of steroids and instructions for scheduled Benadryl for the next 24 hours. Other Relevant History.

Severe aches, fever, chills, joint & muscle pain, headache started coming on about 8 hours after 2nd vaccine & got worse through the night. Couldn?t sleep, left arm & left side of neck were sore & hurting in the beginning, then spread to my entire body. (1st vaccine 3 weeks before, no problems except my left arm was sore for a day.) Took ibuprofen & alprazolam before getting in bed & it seemed to help for a short time. My nerves felt like they were on top of my skin. Didn?t sleep much at all, maybe couple hours. Now, 3pm the next day, I?m still very sore, tender all over my body.

After adminstaration of medication, patient had light headedness, nervousness, anxiety induced symptoms. Paramedic came and took vitals signs and ekg vital signs are stable . As her smptoms dessipate she was release by the nurse.

Restlessness, pain at sight of arm, unable to sleep that night, agitated, sweats, heaviness in chest, no care attitude, muscle pain, headache, nausea- emptiness in stomach, possibly swollen lymph nodes. This continued until 6pm the next day (3/25/2021) after receiving the covid vaccine. Should I get the 2nd vaccine, scheduled for 4/15?

Fatigue: I had Covid last summer and experienced fatigue for several months. I felt better by the Fall but fatigue returned after my 2nd dose of the vaccine. Unable to work for normal 8-9 hours/day. This has been for the past two months. Symptoms seem to be getting better slowly. Tinnitus: I had mild tinnitus prior to the vaccine but it has increased. No change in the past two months.

severe neurological symptoms of limb parasthesias gradually decreased over six weeks , vision loss intermittent left eye for 5 minutes at a time ( 5 events over one month), continued to this day intermittent diplopia vertical , with blurring vision and eye fatigue , general fatigue with ADL ( missed multiple days of work), bouts of tachycardia and palpitations ( slowly abating over 6 weeks ) , original neck pain and headache severe in first 2-3 weeks especially after second vaccine 1/29/21 lot number EL3246. multiple MRI's done brain ( white matter and demylination dating back to before 2015) and cervical and thoracic spine showing existing disc disease all old , neurology work up was done for MS and it was ruled out. visual disturbances persist and neuro-ophthomologist appointment schedule for mid april .

Patient recieved the vaccine and her husband stated his wife didnt "no where" she was and was confussed & dizzy. Patient appeared diapheretic. Onsite EMS was called at 2:42pm HR 64 BP 76/47 Blood pressure did not recover by 2:58 pm and refused transport to the hospital.

Adverse systemic events for the duration of March 17-March 27: Swollen lymph glands (mild) Fatigue (severe) Brain "fog" (severe) Sensation of overheating / burning Fever (few mild elevations) Loss of Appetite /Indigestion (resolving as of March 26)

I am still weak and tired 5 days later. I nap (highly unusual for me) and feel better for a little while but if I do anything I get weak and tired again. I get feeling fogginess like I'm lost in a fog and can't even function. Then I lay down and I get feeling better. I keep thinking I'll shake it and get well but this has been going on for five days now. Also I have never had a headache in my life, but I am getting recurring small headaches. And I just feel weird, not right.

bad headache, high fever, body ache, no energy, slept all day/night Now brain fog , blurred vision low energy

Please know that this point there is no emergency, but I am furious at the enormous side effects I've endured on the 1st and 2nd vaccine My 1st vaccine was March 5th at 10:30 am . Next day I had a slight fever and was exhausted all day long. I had to keep laying down after being up for an hour. 5 days passed and I was in the grocery store and my legs were on fire and I had huge Welts -hives all up-and-down my legs . I started to faint and the woman in the bakery sat me down until it passed. I had a headache and a slight fever after that . I also had a enormous sneezing fits, of which there was no apparent trigger. At the time I just chalked it all up to allergies or something un related to the vaccine because so many days had passed. I received my 2nd vaccine on March 26th at 8:00 p.m. at the Farm stadium. The next day my arm was a little sore, nothing unusual. The following day I was a little tired again nothing unusual. The 3rd day ( Mar 29) all hell broke loose. I got the hives all over the place, I could not stop sneezing . I've got a massive headache, and I can barely stay awake over an hour without taking a nap. I am absolutely miserable! I wish I had never taken the 2nd vaccine. This may not be life-or-death, but it sure as hell sucks. I wouldn't recommend the vaccine after this experience . And if it's anything like my 1st vaccine, I've got a week of this to endure

runny nose since day after getting shot; nervous about second shot; worried; facial neuropathy flare; facial neuropathy flare; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6201, expiry date not reported) via an unspecified route of administration, administered in left arm on 25Feb2021 08:30 at a single dose for COVID-19 immunisation. Medical history included facial neuropathy, sleep apnea from 2003, and Guillain-Barre syndrome from 2001. Patient said she had Guillain-Barre syndrome 20 years ago and has residual neuropathy from that. There were no concomitant medications. Patient have not had any other recent vaccinations or started any new medications. Patient called about the Pfizer COVID-19 vaccine shot, as she was supposed to call about possible side effects, to report. She said that she had her first dose of the vaccine on 25Feb2021 and hasn't had her second yet. She said that the first dose was injected in the morning, around 08:30AM. She said that there was a sticker on her vaccine card that says mRNA Pfizer-BioNTech, and (withheld), she didn't know what that means. She said actually that was abbreviation for (withheld), her vaccine provider. Her side effects included fatigue on an unspecified date in 2021, which she thinks a lot of people do have. She didn't know if this was available but she was hoping to advice about getting her second shot. She has had a runny nose since day after getting the shot, so since 26Feb2021, it hasn't stopped. She was not saying this was from the shot, it could be chronic runny nose, but it didn't stop. She said that the worst thing she was calling about was she has facial neuropathy flare in 2021, described as slight facial neuropathy which felt like it has flared since the shot. She was calling because she was nervous about second shot in 2021, since it flared with the first one a bit. She didn't want this to get worse, she can live with it currently, but she has heard people have more problems with the second dose and she didn't want to risk full blown neuropathy. She has done no treatment for the neuropathy, but for the runny nose there were a couple nights she took Benadryl and today she took Claritin, so put that she has taken sporadic over the counter stuff. No further details provided about Claritin or Benadryl. She has been experiencing continuous runny nose, flare of facial neuropathy, and fatigue. She was worried in getting the 2nd dose in 2021 and wanted to have recommendations as her doctor was reluctant in giving an advice whether she may have the 2nd dose or not. The patient reported that facial neuropathy flare as serious medically significant while the other events was non-serious adverse events. Patient was advised by the Pfizer colleague of the overall safety summary that indicated throughout the safety follow-up period to date, Bell's palsy (facial paralysis) was reported by four participants in the Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of Bell's palsy were reported in the placebo group. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19. The outcome of the events facial neuropathy flare, fatigue, nervous and worried was unknown. The event runny nose was not recovered.

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: clamy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Medium, Systemic: Weakness-Medium

Woke up at 3am on second morning after vaccine with extreme dizziness and nausea. Continued to have dizziness, nausea, and dry heaves until following day. Could do nothing but sleep. Lightheadedness continued through the next day after that but nausea passed.

Sore arm for 1/2 day after shot was expected. However, one week after injection (3/39/21), I became dizzy. The next morning (3/30/21), I was extremely dizzy, very nauseous, and had a severe headache. I was hardly able to get out of bed, and unable to work that day. Symptoms lasted until the morning of 3/31/21.

0650: Pt in observation after receiving 2nd dose of Covid vaccine. Husband present. Pt states felt a "rush" , urge to swallow over and over, legs shaky, feeling claustrophobic. Hx of feeling similar when having shell fish or receiving contrast. Water given feeling somewhat better. BP 175/93, HR 75, O2 sat 100% 0655: feeling increase salivation and urge to swallow. 0700 Benedryl 25mg po given with water. BP 157/76 HR: 68 02 sat 100% 0715: Pt states feeling much better, salivation and urge to swallow gone. BP 139/63 HR 67, 02 sat 99% 0725 Pt states no further c/o of anything. Ambulated with husband to car.

Client is observed in Observation area x30 min, didn't complain any symptoms. Client went back to her vehicle, and c/o lightheadedness and anxiety. Vital signs taken: BP 119/68, HR 85, SpO2 99%, RA, RR 18/min. Client is provided with hydration and snacks. Client is directed to lay down in her car seat, open the car windows and turned on AC, and observed for another 25 min. Client stated "My energy is back". Client refused 911 services, and stated she could drive home. Client left POD at 10:46am without symptoms.

pt. c/o feeling little tightness on her throat. She is able to swallow. seems anxious resolving. Hx - anxiety

Pt arrives to the observation area after receiving her vaccine. she states she has known vertigo for some time and "feels loopy in the head after the injection" 1329 BP 140/ 79 HR 60 Oxygen sat 98% room air given water to drink 1335 BP 145/79 HR 58 oxygen 99% room air patient tolerating oral fluids 1350 BP 152/82 HR 57 oxygen 100% room air pt feeling better she states that her head is back to normal, she tolerated two bottles of water 1400 pt was released from observation and escorted to the exit with staff her daughter was in the parking lot to take her home

Received the Covid-19 vaccine. She reports symptoms of Other: Shortness of breath and "feeling funny.". I have observed patient feeling anxious and uncomfortable. Treatment/intervention /vitals taken: B/P 124/82, pulse 104, RR 16, Oximetry 98%. Recheck p- 82, oximetry 100%. Lungs were clear bilaterally. Patient stating that she was feeling much better. Offered her water to drink. Staff remained with patient until she was feeling comfortable enough to leave. When leaving, she stated that she was fine and needed no assistance. Ambulatory.Agency report submitted: yes Agency Report number:

Nausea, so far three days Sweats and chills. Temp reading normal Severe headache 2 days Sleeplessness four nights Extreme fatigue

rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso, had it on legs/face was so red like the rough sunburn feeling; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Felt dizzy and weak/had less energy today; Dizziness and lightheadedness /felt dizzy and weak; Worst and really sharp Charlie horse between ankle and calf- took forever to walk; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Anaphylaxis due to vaccination; Vomited; Major diarrhea; She was so cold that her toes were purple; Blood Pressure so low: 58, couldn't find a bottom number at first but then at the hospital it was 58/38; Face was extremely pale; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; Too cold to function or do anything; Nauseated- almost like morning sickness/Extremely nauseated/queasy feeling; Nauseated- almost like morning sickness; very extremely tired; creatinine /it was still high; sick; body temperature was low; She thought she was going to die because of the purple toes; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; her body catching up on sleep or she's just tired; This is a spontaneous report from a contactable consumer (patient herself). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration, on 11Mar2021 as single dose in left arm for COVID-19 immunisation. Medical history included ongoing High Blood Pressure (It's under control now, fairly healthy; diagnosed probably when she started menopause in early 50s), ongoing Anxiety (Diagnosed probably when she started menopause in early 50s), ongoing Sinus headache (Worst sinuses; Takes Excedrin because Tylenol does not have an effect on her), ongoing smoker (Pack a day, but smoking about only about half of it each time. started when she was a teenager. She was without a cigarette for 3 days in the hospital, but when she came home she had to start again), menopause (in early 50s), shoulder- torn rotator cuff-operated in 2018. Family history included cardiac and heart disease, Parkinson's and Frontal lobe dementia (husband). Concomitant medication included colecalciferol (VITAMIN D3) 1000 IU, once a day, by mouth (Taken these for as long as she can remember, they kept advising it, husband takes it for Parkinson's so she just throws one in for her), calcium ascorbate (VITAMIN C) 1000 IU, once a day, by mouth (Started at least 2 years ago, doesn't drink enough orange juice, doesn't do fruits, doesn't get enough Vitamin C), linum usitatissimum seed oil (FLAXSEED OIL) 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for cardiac and heart disease, takes as preventative, fish oil 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for family history of cardiac and heart disease, takes as preventative, hydrochlorothiazide, lisinopril 20/12.5 mg, once a day, by mouth (She has been taking this medication for years, under control with this medication) for High Blood Pressure, lansoprazole from 2020 30 mg, once a day, by mouth (Started years ago) for Stomach pill for acid reflux, duloxetine hydrochloride 60 mg, once at bedtime, by mouth (Started forever ago) for just being achy and anxiety, lorazepam .05 mg, 1 tablet 3 times a day, takes one tablet a day at bedtime, by mouth for Anxiety (Started this a while back- with the heart disease and everything else, gave this to help with menopause symptoms too), meloxicam 15 mg, at bedtime as needed from 2017 for back issues- really sore at times, takes if really stressed or she overdoes it. Patient previously took Tylenol for sinus headache and does not have an effect on her. After the first dose of the vaccine the patient reported that she was extremely tired on 11Mar2021. She was completely nauseated most of the day on the second day. On Saturday, she was extremely nauseated (12Mar2021) with vomiting and major diarrhea on 13Mar2021. By 4 PM that afternoon (12Mar2021), she could not function because she was so cold; she felt like she was in a really bad dream and couldn't wake up. She called on 13Mar2021, her blood pressure was so low-they got 58 for the top number, they were unable to pull up bottom number at that point. patient reported that when the ambulance arrived, they described her face as extremely pale on 13Mar2021; her major complaint was that she was so cold- she has never been that cold in her life. When she got to the ER- they had to use the old blood pressure cuff to get her blood pressure because it wasn't coming up on the machine- the kind where you pump it up and watch the needle, they said it was 58/38. patient states that they asked her about the rash that was all over her body in 2021; caller reports that she did not have a rash when she called at 4 PM. patient describes the rash as an extremely red sunburn rash- like you got really bad sunburn, most of it was on her torso, she also had it on legs on 13Mar2021. patient mentioned she remembers them taking off sock and her toes were purple on 13Mar2021. She also had a red on her eyelids- she described as itchy and swollen on 13Mar2021. patient mentions that unbelievably as sick as she was in 2021, she could understand everything that they were telling her. Treatment was given as they prescribed her Prednisone and Benadryl; she was also hooked up to an IV, and they were trying to warm up her body because body temperature was low in 2021. Discharge paper reads as anaphylaxis due to vaccination on 13Mar2021. patient states that she came home from hospital on Monday, 15Mar2021. patient reports she started a diet. 2nd day (12Mar2021)- From the time she got up, she was too cold to do anything; she couldn't walk and she was feeling like she was getting the flu. Saturday (13Mar2021)- She woke up and had the worst Charlie horse between ankle and calf- took forever to walk Charlie horse off. Really sharp Charlie horse. Even had less energy today. Really nauseated. patient reports that yesterday and today, she is just tired. She doesn't know if it's just her body catching up on sleep or she's just tired; she will find out today when she goes to doctor. Caller mentions that she is normally more active than she feels right now. patient reports her eyes have been itchy and she has a rash on her eyelids. patient doesn't know if it's from the shot; patient mentions that she decided on 01Mar2021 she would start a diet, get healthy, and see a nutritionist. patient reports that initially she didn't think her symptoms were from the vaccine and thought it was that she wasn't eating enough food on Friday. She got in touch with the dietitian. patient reiterated she did not attribute this to shot right away. patient reports that she was wondering if she had asymptomatic covid, and it would have been within a 3-month period that she reacted to the shot. She was not sick if she did have asymptomatic covid. There still trying to figure out why her body had this reaction. patient states that every now and then she was still cold, but she doesn't know if its her imagination and plus it is cold outside where she is. She is still on the cuff on that one. patient describes the nausea she first felt as almost felt like morning sickness on 12Mar2021-that's why she attributed it to her diet. patient mentions that the day she started feeling better, late Sunday afternoon, she wanted salty foods. Anything salty, chips, she just really wanted salty stuff. She was not normally a salt person, but the saltier it was, the better it was. patient reports that when she was vomiting with diarrhea and laying down, she would be throwing up in a towel because she couldn't make it to the bathroom when she was laying, it would just gush. patient describes it felt like her body was going to be locked into the position it was in, she doesn't know how to describe it. patient states that she had vomit on her clothes when she called. patient reports the nausea stopped late Monday and the queasy feeling went away. patient reports she stopped vomiting when they gave her Zofran- they had to give her a couple because she didn't stop throwing up right away. patient reports she was extremely dehydrated and her kidneys were showing some damage; her creatinine level was really off on 13Mar2021. The diarrhea was gone, but now she has a mixture of soft stools and semi formed. It is trying to improve but hasn't yet. patient states that because of her creatinine level, they did want her to drink and she might have soft stools because she was drinking so much. patient reports she knows when her husband put the shirt on her she did not have the rash, but when the ambulance arrived, they said she had the rash. Upon discharge, they told her not to receive any further covid vaccines- she cannot get her second one which was scheduled for 01Apr2021. She started experiencing the really cold feeling on 12Mar2021 after receiving the vaccine. She went to bed at 7, that's not like her, she was usually up all hours of the night. symptoms she was experiencing were beyond typical. patient reports she also felt dizzy and weak on 13Mar2021. She thought she was going to die because of the purple toes in 2021- she knew that was a sign of her body shutting down and she got the most scared. patient mentions she is experiencing a residual side effect from the covid and influenza tests-both were negative on 13Mar2021, but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph in 2021. patient reports she feels human today, but she is still sleepy in 2021. She thinks she would feel a whole lot better if her nose stopped running. The tiredness might be from nose blowing and stuff. patient remembers the nurse was thrilled that her toes weren't purple anymore. It started going away when her blood pressure and everything came back up. patient states that she was so scared that she was dying so she remembers everything that happened. patient remembers she was in the ER still when her blood pressure improved. Treatment for her face was so red like the rough sunburn feeling and putting moisturizer on the dried cheeks. patient reports that she doesn't see any patches of red on her. Part of her has a fear that the stuff is not totally out of her system and it will happen again. patient mentions she has heard comments that this was not a typical reaction from the first one and wants to know if it is typical to be that sick from the first dose. patient reports that now her eyes just feel like she's allergic to something. She doesn't know if the redness is from crying now- it was improving, but was still there. Husband has Parkinson's and Frontal lobe dementia and she is his caregiver, she cannot afford to get Covid, she wants to get back to normal. patient reports that she did not take any of her prescriptions the day of the vaccine, she did not want to get a reaction. patient reports she had her shoulder- torn rotator cuff-operated on in 2018. If nose is really stuffed up or allergies, or Fluticasone nasal spray- she can take it 2 times a day, 2 squirts in each nostril, take it as needed. patient reports that she has the worst sinuses- when it gets too bad, she'll go to the doctor and she'll prescribe Flonase, take Metamucil or whatever she thinks will help with sinuses. she still wants to get the second vaccine. patient reports her creatinine came down well enough that she could come home from the hospital, it was still high on 15Mar2021 so they told her to drink lots of water so she does not get dehydrated. Patient was hospitalized from 13Mar2021 to 15Mar2021 for Anaphylaxis, Tiredness, Nauseated, Morning sickness, Vomited, Activities of daily living impaired, Walking difficulty, Flu like symptoms, Pale, Photosensitive rash, Asthenia, Dizziness, Charley horse, Dehydration, Renal disorder, Creatinine low, Cold, Diarrhea, Purple toes syndrome, Blood pressure low, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid. For rash also patient was hospitalised. The outcome of Vomited, Pale, Photosensitive rash, Dizziness, Asthenia recovered on 13Mar2021, Nauseated, Morning sickness recovered on 15Mar2021, Activities of daily living impaired, Walking difficulty, Flu like symptoms recovered on 17Mar2021, Diarrhea, Cold, Blood pressure low, Purple toes syndrome, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid were recovering, Tiredness and Creatinine high were not recovered, while remaining events were unknown. No follow-up attempts are possible. No further information is expected.

Patient DOB 9/6/57 received her first Pfizer Covid vaccine, then became dizzy, "I feel like I am drunk" Patient laid down on an exam table, her husband brought her cookies and water, Patient stated that it had been several hours since she last eaten, left the clinic with her husband as an escort without incident

1st shot was similar, it felt like something popped and my sinuses got crazy, my eyes got watery and swollen, my throat was like a stiff neck, my head hurt so bad i was taking tylenol every 4 hours, at night i got a fever and my husband said i was crying for a blanket, I think I might have gone back to when i was at the hospital, I don't know, we both couldn't walk or move everything hurt so bad. The second shot was worse than the first.

Within 15 seconds of second Pfizer CV19 vaccination, given at appropriate interval from 1st dose, patient experienced cough. I noted that the patient coughed as she exited the vaccine area to the observation area that was manned by a Registered Nurse. The RN came to the vaccine area to ask me to help with the patient while she waited in the lobby with another RN. The patient was sitting in a chair, flushed, distressed, experiencing shortness of breath and repeatedly coughing. EMS was already called. I pulled up 0.3mg of epinephrine which was administered IM in the right lateral thigh and 25mg of diphenhydramine 25mg which was administered IM into the upper left deltoid, the opposite arm from the vaccination. EMS arrived and took the patient to the emergency room approx. 1 mile from the clinic. She received methylprednisolone 125mg IV, famotidine 20mg IV, and nebulized race-epinephrine upon arrival. She was discharged home with prescriptions for prednisone 20mg daily x 5 days and an Epipen.

63 y/o female with PMH of GI issues, s/p ileostomy c/o pain (4/10) in her left shoulder and left SCM. Pt was assessed by clinical leads and a heat pack was applied to her left shoulder. Pt was re-assessed 2 minutes later to monitor symptoms. Pt appeared diaphoretic, pale, complaining of dizziness + nausea. Ice packs were applied to her neck and forehead and EMS was called to monitor vitals, lay pt on a stretcher, 2L O2 via nasal canula. Pt reported "feeling awful" and did not respond to any questions, pt maintained consciousness throughout the entire encounter. Pt was attached to a monitor and a 12 lead EKG was obtained that showed evidence of a wide QRS, new right bundle branch, prolonged QT and T wave changes. Pt denied any cardiac history or history of abnormal EKGs or similar prior experiences. She was immediately transported via EMS to the Hospital Emergency Room for further evaluation, pt gave consent for transport. Pt denied notifying / calling a family member or friend to inform them. Denies chest pain, LOC, SOB, respiratory distress, vomiting, itchiness, erythema, swelling, HA, similar prior experiences PMH: weak pelvic floor, IBS, imbalanced gut flora, ileostomy for unknown reason - DENIES history of: cardiac issues, pulmonary issues, diverticulitis, cancer, autoimmune conditions (ulcerative colitis, crohns) Surgical History: ileostomy, C-section Meds: Linzess, Motegrity, Baclofen, Liothyrozine Vaccine was administered at 11:48 am in the left deltoid. Pt began experiencing symptoms at ~ 12:03pm. General: A&Ox3 HEENT: NC/AT, EOMI, PERRL, airway patent, no trismus MSK: tenderness to left SCM, neurologically intact b/l, brisk capillary refill b/l, radial pulse 2+ b/l, full ROM b/l, 5+ strength b/l Skin: diaphoretic, pale Pulmonary: clear to auscultation b/l Vitals: @12:09: BP: 74/52, HR: 53, SpO2: 96% RA, @12:12 2L O2 NC @12:13: BP: 106/73, HR: 72, SpO2: 97% 2L NC @12:15: SpO2: 99% 2L NC @12:16: BGM: 118 @12:20: BP: 112/77, HR: 69, SpO2: 100% 2L NC

Horrific pain in left arm, shoulder, neck every day since the first injection. Pain is 24/7, ongoing, causes lack of sleep, severe discomfort, inability to function

Pt reports difficulty swallowing, numbness to lips and mouth area, sensation of eye swelling. Pt appears anxious. Medics on site for evaluation; VSS. Pt left AMA.

Fever, chills, very sore arm, brain fog, achy, nauseous, back pain, very tired. Went to bed at 6 pm. Woke up at 6:30 am with all symptoms gone, except a one degree fever, brain fog & tired. Took 500 mg Tylenol at 1 pm on 4-7-21. Took two naproxen 220 mg each at 9 pm on 4-7-21. Took Tylenol 500 mg at 9 am 4-8-21.

Only initial side effect following both injections was moderately sore arm and fatigue. Following 2nd dose I experienced 1 episode of severe vertigo while just sitting doing nothing. Dizziness cleared completely in about 4 minutes. Then on March 13th, was at work, sitting at desk and same thing happened again. After the dizziness cleared I got up and went to see a patient. I work in a rehab unit of a hospital. Got pt approx 50 feet down the hallway when dizziness started coming back. Handed patient over to other staff. I took my blood pressure and checked my blood sugar. Both WNL . Dizziness never got better. Went to ER. They had no clue of cause. All labs were normal. Saw Physical therapist who performed Eply maneuver as well as a ENT. Both got same result. Negative for BPPV. MD gave me Antivert. Didn't work. Are waiting to be seen in May 2021 for NVT test and another with Neurologist. In the meantime the dizziness has remained constant rendering me unable to return to work.

First day a little sore arm,(Monday) The second day was BAD.(Tuesday) As the day went on it got worse. That evening I did not sleep all night. I was having very intense throbbing pain from my wrist, up my right arm (same arm as the shot was given), up the right side of my neck, pain down my right side of my back and into my lung area. The pain just spread until it was on a scale of 1-10 it was an 11. It also spread to my lower back. The next day,( Wednesday) I still had all of the pain. Thursday I just have soreness in my upper shoulder blade area. This was very scary! I even took some aspirin incase of blood clotting. Tylenol did nothing. If I would have had a very strong pain pill I would have taken it. Now I am afraid to get my second shot which is scheduled for April 26th. I need some guidance from you on this.

Started with Chills, headache, aches and pains in joints and muscles. Body feeling heavy. Got up to use the restroom around 2:45am and got nauseous and very hot and passed out for about 15 seconds. Woke on the floor which cooled me down, drank some water and went back to bed. Next morning I got woozy and had trouble standing. Slept most of april 8. April 9th felt better.

Cold chills, sinuses clogged & running, heart fluttering, head soreness, ringing in my ears, exhausted feeling shake feeling.

Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Headache-Severe, Systemic: Unable to Sleep-Severe, Additional Details: Day after immunization, Tuesday, patient reports she had severe pain at injection site, arm,back and neck,including headache. There was no inflammation or redness at sites of pain or injection site. She took aspirin and slept most of the day. On Wednesday morning, still had pain, was not as severe. Today, Thursday, some pain in back still, but much better. She is mostly concerned as to whether or not to receive the second shot in a few weeks. She would like someone a follow up call

Event woke her up; feeling really bad; kind of sick at her stomach; fatigue, tired; really nauseous; Really, really sick; This is a spontaneous report received from a contactable consumer (patient). This contactable 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6198) via an unspecified route of administration in the right upper arm on 06Mar2021 at 13:30, reported as about 13:30 to 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes mellitus from 2001 and ongoing, high blood pressure from 2001 and ongoing, and chronic obstructive pulmonary disease from 2001 and ongoing. Concomitant medications were not reported; the patient stated she'd been taking them for years and they were not relevant to these events. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of BNT162B2 on 06Mar2021 around 13:30-14:00. She reported being really, really sick later that day on 06Mar2021 and called to inquire if this event could be related to the vaccine and asked if she had to get the same type of COVID-19 vaccine for both doses, or if she could get a different manufacturer's COVID-19 vaccine for the second dose. She reported really, really sick initially onset around 19:00-20:00 on 06Mar2021 and continued for 2 days, until around 08Mar2021 then she felt better. Starting 09Mar2021 around 19:00-20:00 she started feeling really, really sick again like she was on 06Mar2021. She was feeling really bad, kind of sick at her stomach, really nauseous, fatigued, and tired. The event woke her up around 06:30 on 11Mar2021. She further reported the ongoing event is about the same as initial onset, persistent. Regarding bloodwork performed about a month or so before being administered BNT162B2, approximately Feb2021, she reported that they had corrected her low iron and low B12. The events did not require hospitalization. The clinical outcomes of really, really sick, feeling really bad, kind of sick at her stomach, fatigue, tired, nauseous and event woke her up were not recovered. Follow-up attempts are completed. No further information is expected.

Loss 0f appetite. excessive sleeping for 3 days. Light headed upon arising. body aches, coughing up thick mucus. condition lasting 9 days after covid19 shoot.

Received vaccine at 10am CST 04/09/2021. By 6pm, whole-body chills had set in, as well as whole-body joint pain. Fever was 102. Took 2 Ibuprofen for the aches and 2 aspirin for the fever. Retired 0930pm. On 04/10/2021, awoke at 0730am, feeling fatigued, but chills were reduced from previous evening. Continued with ibuprofen and aspirin. Went back to bed, as still feeling fatigued and chills. Temp 101. By 0200pm, feeling better but not normal, so continued ibuprofen/aspirin regime.

Severe shaking of body, mainly arms and legs on 4/1/2021. Lasted on and off for 2 hours. Feeling very dizzy, slightly nauseous and my skin was crawling. Felt intoxicated. Tried to stay calm. Had taken Advil pm and went to sleep. Woke up the next morning feeling shaky, difficulty walking. Slight headache on top of head. Blurred vision would come and go. Took 1/2 Prednisone 20 mg (which I take when migraine severe). Felt better early afternoon. Again shaking while sitting down late afternoon 4/2/2021. Feeling weird. Slept through night. Next day only one episode of shaking. During 10 days afterwards still periods of getting dizzy, feeling my heart beat in my ears, at times feeling confused, when typing my left hand sometimes fails to respond.

On Friday, the next day less than 24 hours, I broke out in a rash, hives/whelps, on my arms, torso, upper legs, that was itchy and very uncomfortable, I took 2 Benadryl about 5pm, then 2 more about 9pm, went to bed and woke up several times during the night itching, Saturday morning took 2 more Benadryl and it started to fade and was less itchy, I felt achy and my knees hurt, I have arthritis in my knees. Saturday evening the rash/hives came back and today my knees are extra achy. Today, Sunday, still achy and a little of the rash still visible. Wondering if I should get my 2nd shot in a few weeks.

(This is actually my second ?First? shot because the first one was deemed possibly ineffective due to storage issues.) My right arm was pretty sore starting about mid-afternoon, so sore it hurt to move it. I took tylenol at bedtime and my arm felt better in the morning but I started feeling really achey and tired. I ended up sleeping for another 2 hours, from 11am to 1pm. My body was really sore...shoulders, my right armpit, hips, lower back, knees, thighs. More so than normal. Lasted the full day after the shot. Felt much better on the 3rd day (April 11, 2021)

For the first several days I had loud ringing in my ears and pressure in my chest. Then, I experienced a full-blown flare of my encephalitis symptoms: constant nausea, dread/doom/anxiety/panic, memory loss, loss of balance, extreme fatigue, weakness, sleep disturbance, GERD, depersonalization, bizarre ideation.

Pt called to report symptoms post pfizer vaccine #1 which she received on 4/7/21. She began to experience symptoms 12 hrs after vaccine administration. She felt faint, "pins and needles" all over her body, and particularly in her lips. She reports feeling "wired" even though she was very tired. She experienced nausea and chest tightness the next moring. Her symptoms were gone by 4pm 4/8/21. She is reporting this as she is worried about vaccine #2, scheduled for 4/29. Allergy consult placed, and pt encouraged to contact her PCP re need for any cardiac work up.

This was my second shot. Just for background, my reaction to the FIRST SHOT was minimal (slight headache) until the 2 WEEK mark (after my checkin) when all of a sudden I had **5 canker sores in my mouth (both cheeks/ NOT cold sores) and also a ** buzzing in my ear. I received my second shot on 3/26/21 .. minimal reaction except sore arm - until 2 WEEKS exactly (again.. and after check in). ****Enlarged inguinal lymph node on right side with pain and sleeplessness. Over an inch... maybe the size of a pecan in its shell?? No sign of infection - as far as I can tell - no urinary burning or pain. no extra discharge, etc.. no cuts. also, continued buzzing in ears and sores on tongue and lips - all at the 2 week mark. FYI, the enlarge lymph node, ear buzzing and multiple canker sores are highly unusual for me!!

About 17 minutes after the administration of the vaccine the patient refer that she started to feel dizziness, tremors, daze and weakness

This was my 2nd shot. First was given 3/16/21. No issues with first shot. After 2nd shot - Large canker sore under tongue day after injection. Diarrhea on 4/6 and 4/7. Friday 4/9/21 blood pressure spiked to 180/128. Eventually came down to 150/101. This was determined at a doctors office where I was to have a minor surgical procedure. Had to cancel due to BP so high. 4/7 through today 4/13/21 have felt anxious, difficulty sleeping and weird dreams when I do, hot flashes and itching at night , lethargic, loss of appetite, dizzy, anxiety, general feeling of being unwell. I thought it was important to report these side effects as they are not the usual ones listed for this vaccine. I have heard other people having similar side affects as me.

Pt received second dose on 04/02/2021 no adverse effects noted at this time. Pt contacted customer service on 04/13/2021 in regards to second dose vaccine administration. Pt reported " shortly after, they experienced extreme pain in arm and shoulder making daily activities difficult". Pt contacted PCP and told that they"re "experiencing SIRVA from vaccine being administered too high in arm"

Experienced extreme vertigo with nausea & vomitting, brain fog, headaches, sweats, eye twitching, pressure my head, questionable vision changes

On 04/04/2021 after having memory issues I went to the emergency room and was diagnosed as having 3 strokes. I woke up with a throbbing headache and then had difficultly remembering simple things like using the remote control for TV. My vision was also somewhat blurry. I then went to drive and my focus was off making driving difficult so I then went to the emergency room

Trouble Breathing Blood Pressure spiked to 170/110 Lightheaded Confusion Slept from 6pm Friday after the shot till Monday morning @ 7am. Awake for short period of time 2 or 3 hours intervals Night sweats and bad dreams Left arm never hurt at all Neck pain on left side Pain moved to my back Entire body aches and soreness Trouble seeing clearly Today - Thursday April 15th I am feeling much better this afternoon Blood Pressure back down to 134/78 All other symptoms have subsided

Patient received her second Pfizer vaccine and within 10 minutes of the administration, the patient had a rash and was itching. Patient stated she did not feel right. A rapid response was called, Benadryl IM was administered and patient was transported via wheelchair to Urgent Care.

Day 1 and 2, extreme fatigue, pain and aches in my hips and buttocks which subsided each day but lasted 4 days until Sunday 4/11/21. Monday at 1 am I was woken up from a deep sleep by a severe twitching on the right side of my face, below my cheek bone pulling the corner of my mouth up. This lasted about 1 minute. Monday I felt a little numb in the area. By Tuesday, the 12th, I felt 90% back to normal regarding each of these side effects.

Headache and discomfort for duration of initial day. Itching and rash on site and on arm/hand where shot was given. Following day(Sunday) experienced more headache and muscle aches and joint pain. fatigue. Some abdominal discomfort and intestinal distress.These symptoms lasted ino Monday. Monday did not work, continued to experience flu-like symptons. felt chills but did not have fever above 99 during any of time. Abdominal discomfort continued through Tuesday

intracranial pressure; angioedema near her ears and the gland secretes and the passage way swells up; rush of pressure to back of head and the lower part of head; Headache; dizzy/Dizziness/light headed; out of body experience like floating; my arm started to really hurt/Sore Arm; sore to touch; cloudy and pressure in her ears/Ear Pressure; vertigo issues; vestibular migraines; patient can't walk; tunnel vision; eyes felt funny. States like walking through a stream of pollen, not that she had itchy eyes, but it felt like she had been effected by something; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Left Arm on 01Apr2021 about 13:30-14:00 pm (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Hashimoto's disease, Diagnosed 13 Years ago, patient was allergic to penicillin and Avalox (anaphylactic and I am sensitive to medications). Don't know if this happened when she got Hashimoto's, Thyroid, ongoing Vestibular Issues Started 5 years ago. States one doctor thinks it is her bad neck. States when she got old things shifted and changed. One ENT said she has neuritis, where something hit her ear nerve in right ear. States hence that was what the acyclovir was for, when she feels an earache coming on, she takes acyclovir. No previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks). AEs following prior vaccinations: None; reported she hadn't had any flu vaccines in years because of the ingredients. States because of her Hashimotos because of everything with her health it was not conducive. Last one was 2014. Concomitant medications included guaifenesin (MUCINEX) taken for hypersensitivity from an unspecified start date and ongoing; fexofenadine hydrochloride (ALLEGRA) taken for hypersensitivity from an unspecified start date and ongoing; levothyroxine sodium (LEVOXYL) taken for thyroid disorder from an unspecified start date and ongoing; azelastine hydrochloride (AZELASTINE HYDROCHLORIDE) taken for hypersensitivity from an unspecified start date and ongoing; aciclovir (ACYCLOVIR ACTAVIS) taken for ear pain from Mar2021 to an unspecified stop date; naltrexone (NALTREXONE) taken for autoimmune thyroiditis from an unspecified start date and ongoing; alprazolam (XANAX) taken for an unspecified indication from an unspecified start date and ongoing; magnesium (MAGNESIUM) taken for an unspecified indication from an unspecified start date and ongoing; fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported; curcumin (TURMERIC MERIVA) taken for an unspecified indication from an unspecified start date and ongoing; 7-keto-dehydroepiandrosterone (7 KETO DHEA) taken for an unspecified indication, start and stop date were not reported; ferritin (FERRITIN) taken for an unspecified indication from an unspecified start date and ongoing; boric acid, zinc sulfate (OPTIZINC) taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; lactobacillus reuteri (PROBIOTICA) taken for an unspecified indication from an unspecified start date and ongoing; calcium saccharate (CALCIUM D GLUCARATE) taken for an unspecified indication from an unspecified start date and ongoing; berberine hydrochloride, coptis chinensis, glycyrrhiza uralensis, mahonia aquifolium, phellodendron chinense, rheum officinale, scutellaria baicalensis, zingiber officinale (CANDIBACTIN BR) taken for an unspecified indication from an unspecified start date and ongoing; cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID) taken for an unspecified indication from an unspecified start date and ongoing; alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) taken for an unspecified indication from an unspecified start date and ongoing; pancreatin enzymatic hydrolysate (PANCREATIN ENZYMATIC HYDROLYSATE) taken for an unspecified indication from an unspecified start date and ongoing; levoglutamide (L GLUTAMINE) taken for an unspecified indication from an unspecified start date and ongoing; betaine hcl (BETAINE HCL) taken for an unspecified indication, start and stop date were not reported, Bio Identical Hormone Cream taken for an unspecified indication, start and stop date were not reported. On 01APR2021, she could feel rush of pressure to back of head, tunnel vision, cloudy and pressure in her ears and was dizzy. Hx of Hashimoto's - autoimmune disorder, vestibular issue, concerns with getting the second one (dose). Read about adverse reactions and dizziness was on the list of severe reactions. The instant, within a minute, patient could feel this happening to her, she instantly could feel she becoming dizzy, light headed, out of body experience like floating. (didn't mention this in report) felt like walking on air. While sitting and chit chatting with other people to distract myself. Patient didn't have any anxiety. She will admit she was reluctant to get the vaccine because of my health problems. She was more concerned, she instantly got a headache with the pressure, when she was leaving, she felt her eyes feel weird, almost like an allergy issue, burning, not quite burning either. Kind of like a burning, not quite like a burning, felt like when you walk into the wind that has lots of pollen, that feeling. She didn't walk out side, she was inside when this happened, the pressure was already starting, no headache in front of head, it was in back of my skull, at top of her neck and pressure within the ears and ache and pressure on back of her head. Not dizzy, not like when you are in the hospital and they give she something and patient can't walk, or where you tried to stand and you couldn't , it was more like light headed, like walking on air like. It lasted all yesterday. As the night progressed by 10PM or 11PM her arm started to really hurt, patient took Tylenol and went to bed, took Xanax as she did and slept, woke up fine. This morning it felt like she wanted to have a headache but haven't had it since. It's almost like patient had intracranial pressure, because she had these conditions, so she read a lot. Investigation Assessment was No. States she is calling to report a potentially strange side effect. She states as soon as she got the injection, approximately within one-two minutes, she could feel a rush to the back of her head and the lower part of her head which then made her feel like she had somewhat of her vision clouded, like a tunnel vision. Clarifies her vision was clouded on the sides but she could see forward. Caller states that she was not dizzy like falling over and she does have vestibular migraines and vertigo issues, but she had that feeling of dizziness and when she got up and walked, it felt like she was walking on a cloud. Clarifies she felt a heavy pressure in the back of her head. States as soon as the injection was over, she could feel it. States she is concerned regarding the second dose because of her autoimmune and vestibular conditions. She states is caused immediate pressure in her ears. States that could've affected her and put her into a migraine, she doesn't know. States a friend said jeez you should report that and she read more on the list of side effects and saw something about an allergic reaction and dizziness, and she did have some sort of adverse reaction. States she doesn't know and it is concerning to her. States she is doing fine today, other than a little headache that comes and comes. States it was bizarre with the clouded, not cloudy, but tunnel vision. States she does not want to release any medical records; she declines for now to provide. She states CVS administered it, not her doctor. States she is going to discuss it with him. States she doesn't want to have a worse reaction with the second dose. Caller states a headache is a headache but the pressure she felt within one minute and continuing it concerns her on the second one with the larger dose. States she is also concerned with the second dose if dizziness is a severe allergic reaction, not saying she fell over and wiped out. Patient wondering if that was an allergic reaction. States as the evening went on and she took Tylenol, it improved. States the dizziness improved as the night went on but had a bizarre feeling when she went to bed. States her arm was sore in the evening and is still sore to the touch. Clarifies that her eyes felt funny. States like walking through a stream of pollen, not that she had itchy eyes, but it felt like she had been effected by something. States it was not like a tired and burning feeling, states she can't explain it but something felt like had an allergy type situation if she has a problem with seasonal allergies. Treatment included took Tylenol. States when someone has an autoimmune issue they have a lot of issues regarding the stomach and take a lot of vitamins and supplements. Caller states she wants to report she has a lot of food sensitivities and environmental sensitivities because of her Hashimotos. States anything can set off an immune response. States what happens with that is she would get on her face, angioedema near her ears and the gland secretes and the passage way swells up. States she takes Pepcid AC to treat it. States this did not happen with her first vaccine. States she was very hesitant on taking the vaccine because knows she has these issues and she didn't want to have adverse reactions. States that her reaction to the first vaccine potentially concerns her for the second dose. States going to speak with the medical information department is a good idea. States the location she received her vaccine was very busy. States they did a nice and good job on getting people in. States the girl administering it did good, but she didn't mention unless you knew you had to wait 15 minutes due to possible adverse reactions, they didn't really check on people. States she just had to do whatever and she didn't know whether or not to report it then because she was not in distress. States she thought she just has to get home and drove 30 miles. All events (AEs) did not require a visit to Emergency Room nor Physician Office. The events of Tunnel vision, rush of pressure to back of head and the lower part of head, Headache, dizzy/Dizziness/light headed, cloudy and pressure in her ears/Ear Pressure, was recovered on 01Apr2021, of my arm started to really hurt/Sore Arm; sore to touch was not recovered, of other events was unknown.

The morning I received vaccine 4/6/21, I had no ill effects. I received the vaccine about 4 and 1/2 weeks after having Covid. The next morning 4/7/21 I had severe aches and pains and a fever of 99-100.5. I stayed in bed all day, the fever ended at 7 pm that evening. That evening I went to bed feeling weak tossed and turned the enter night had very severe aches and pains worse than normal my entire body from my neck to my legs, the aches and pains were unbearable. I took cipro at 5 am that morning 4/8/21 due to a UTI infection with a lot of water no food. I got up with the aches and pains I had and felt very nauseous. I decided to shower and felt faint. I passed out for 30-40 seconds on my bed according to my husband when I came to I had no recollection of fainting, This all happened at around 7am. I ate a few bites of a half of a ham sandwich and had juice which helped to get me to feeling a bit better. My husband took my pressure that was very low my doctor who I spoke to said this may have caused me to faint but that the vaccine may have led to this as well. I was weak from it all but started to feel better and I?m fine now. My next vaccine is April 27, I?m afraid to take it but the doctor advised to take it.

Acute vertigo with vomiting started on April 2 at 12:30 in the afternoon. The vertigo and vomiting continued until zofran was prescribed at which point the nausea stopped when I did not move in the bed. Vertigo was constant for April 12th. On April 8th I saw my PCP. She prescribed continued my zofran prescription and added Xanax and meclazine. On April 13th I had a tachycardia event with 114 bpm for 10 minutes. The vagus maneuver worked on my 3rd attempt and my bpm resumed at 70 bpm. I am still experiencing slight vertigo. My gait is not yet steady and I cannot drive because to turn my head brings on dizziness. I am scheduled for my second vaccine Thursday April 22 at 1:00. Needless to say-I am very anxious about taking it. But my cardiologist, ENT and PCP all recommend that I finish getting vaccinated.

Persistent rash after pfizer vaccine says rash started 1 am Thursday after vaccine Tuesday last week. Rash has been on arms, legs, breasts. No difficulty swallowing, breathing at baseline. Went to urgent care after speaking to physician 4/17 and was given topical steroid and referred to allergist. Called back yesterday b/c sx persisted- Prednisone 50mg started yesterday, by HCP and sx are improving. Pt reports long standing hx of GI issues- chronic constipation which causes N/V. She is having a complete workup with GI for this. Vomited once Thursday night when she was constipated, took laxative as recommended by GI and no sx since then, but does get loose stools from laxative. Rash persists on the right arm inner elbow, left elbow rash improving, improving on the legs. She reports previous brain fog is improving. She has chronic fatigue, unchanged for over a year. She reports loss of tastes x 3 days. Denies other URI sx. chronic back pain, no change. She reports hx of recurrent sx like this following new medications, never with vaccines. She will be f/u w/ allergist for further evaluation.

The day after my first dose I started experiencing memory loss. I went to local urgent care and was then transported via ambulance to local hospital. I was admitted to hospital and kept overnight. Diagnosis was Transient Global Amnesia. I remember nothing of my visit to urgent care, the ambulance ride, initial testing at hospital....TGA lasted approximately 4 hours.

I experienced memory loss the day after the first dose...was brought to urgent care and then transported via ambulance to local hospital I was admitted and released the following day. Diagnosis was Transient Global Amnesia. I have no memory of most of the tests and procedures that were administered at urgent care or the hospital and I am still experiencing headaches and brain fog. I believe the TGA lasted approximately 4 hours.

Injection site pain, tiredness, headache, muscle pain, chills, fever, injection site swelling, nausea, feeling unwell. Took Tylenol for pain in arm. Drank a lot of fluids and slept most of Thursday 4/15 to Friday 4/16. Saturday 4/17 fever broke still had a dull headache , no nausea wasn't as weak. Felt better as the day went on. Saturday evening 4/ 17 was back to feeling well.

Suffered 2 major/large strokes in her occipital lobes and small temporal stroke She is now blind, unable to walk, sit, stand, eat by herself, and has speech issues. She is needing full care at this time and unknown what future holds She has been in ICU since 4/17 as we found her unconscious 4/17-she was down by herself tor over 24 hours

Day of injection, started feeling like I was light headed and high, could not concentrate. The next three days, muscles in back of neck and shoulders tightened, hard to lift arms, tired and headache on left side, coughing and hot flashes started on Friday to Sunday with insomnia and diarrhea, saw doctor on Monday . As of today, headache on left side of temple and muscle soreness

Immediate pain upon injection. Burning sensation down left arm. Within a few minutes dizziness/disorientation. 3/19/21 at 1 AM wake to joint pain. Any injury, i.e. broken bone, sprain, etc. ever had was now inflamed & painful. Awake for 2 days due to pain. Overall muscle weakness. Attempted to "carry on" except the worst symptom appeared, BRAIN FOG. Could not remember words that started with s, sc, sh, etc. Would lose my car in parking lots. Couldn't finish sentences. Saw primary care physician on 3/26/21. Ordered MRI w/o contrast on 4/14with no acute process or findings to report. Saw masseuse on 3/26/21 & she wanted to know, "Why are you joints hot?" Symptoms began to subside around 4/19/21.

Symptoms: Empty Stomach, Heartbeat runs fast, Dizzy and Vertigo, headache, fatigue, sweating, sleepless and low blood sugar symptoms. Time Course: It happens when I feel empty stomach, it is around 4 times a day. Signs: Heart palpitations, follows dizzy and vertigo and sweating, I have to drink apple juice or some kind of sweet to relief the symptoms. Doctor Comment: Panic attack or Vasovagal reaction, she prescribed Hydroxyzine HCL 10mg every six hours as needed. I take 1 pill a day before bedtime. As of today, I am still feeling that symptoms around, and that was my first dose of shot. I went to urgent care twice and went thru all testing, and lab test results are Ok. But the symptoms are really bother me. April 29, I will see the allergy doctor if I have any allergy related to the drug

face was swelling, bright red, and very itchy; face was swelling, bright red, and very itchy; face was swelling, bright red, and very itchy; Continued to worsen all day and night. Eyes and lips swelled shut; entire face and neck brilliant red; max amt of itching; neck still red and bumpy; Have been unable to sleep well; This is spontaneous report from a contactable healthcare professional (patient herself). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246), via an unspecified route of administration on 04Feb2021 at 15:15 PM (at the age of 63-years-old) as single dose in left arm for COVID-19 immunisation. The patient's medical history included diabetes Type 2, hypothyroid, shingles 10 years ago. Patient had known allergies. Concomitant medications included Synthroid, Rosuvastatin, Metformin, Tresiba and Ozempic. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no COVID prior vaccination and was not tested COVID post vaccination. On 04Feb2021 at 20:00 by midnight, the patient's face was swelling, bright red, and very itchy. She took one Benadryl. Her face and neck worsened, got into MD in morning. She prescribed Claritin and make appointment with allergist. Patient did both. Events continued to worsen all day and night. Her eyes and lips swelled shut, entire face and neck brilliant red with maximum amount of itching. Patient kept ice on face and neck all night but continued to worsen. She went into hospital Emergency Room at 9:00 AM, received IV Prednisone, Benadryl and one more. Also, prescribed with Famotidine, Prednisone, Benadryl and Tylenol if needed for home. Itching started subsiding, brilliant red remained everywhere, swelling was still significant around eyes and cheeks, neck was still red and bumpy. Patient have been unable to sleep well. She took appointment with allergist 08Feb2021 morning. She wondered if she should take second vaccine and reported that this has been an expensive and emotional nightmare. The outcome of the events was not recovered.

some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headaches; left sided neck and shoulder stiffness; acute weakness; tiredness; severe chills throughout my whole body; generalized severe body aches; extreme joint pains; her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains; numbness; tingling sensations; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 15:30 (Batch/Lot Number: ER 8737) as single dose, for covid-19 immunization. Medical history included chronic interstitial cystitis, hypertension, COVID-19 flu in Jan2021. Concomitant medications included telmisartan (MICARDIS) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (TOPROL) taken for an unspecified indication, start and stop date were not reported. within the first 15 minutes of observation, the patient did not have any anaphylactic symptoms from the covid-19 flu shot. But as patient was driving home, at around 15:45, her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains and numbness and tingling sensations. By around 19:00 that same day, she began having severe headaches, left sided neck and shoulder stiffness, acute weakness and tiredness, severe chills throughout my whole body, with generalized severe body aches, and extreme joint pains, BP of 200-210/100- 110, irregular heart palpitations and some delirium episodes x 2 days. The outcome of events was reported as recovering. The patient has been treating herself with OTC Tylenol and motrin as the result of the events. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the delirium, hypertension and other reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; have massive diarrhea; had a sore throat and could not swallow or eat; menstrual cramps; felt alot of extreme fatigue; felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it; sinus pain; her face and eyebrows hurt; throw up viscously that it is almost coming out of her nose and also went to sheer panic/vomiting; she is not speaking well or understood well; profusely sweating and had whole body sweat drenched on the floor; ice-cold ends; painful arm; baseline temperature is 94.6; Neck pain; Woke up Monday morning and couldn't get out of bed, wanted to die; Caller states she is losing her mind; had her gripping her pelvis because of the pain; sheer panic.; woke up with gut ripping food poisoning; still very tired; couldn't get out of bed; had a sore throat and could not swallow or eat; feel nauseous; feeling dehydrated; her head because of the ache; getting sick; nausea; experienced severe headache which led her to stay in bed all afternoon/her headache is more severe and describe it as she would like to shot her head because of the ache; has a flu-like chills; body ache symptom which comes and go; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration in arm left on 21Mar2021 as single dose for covid-19 immunisation. Medical history included taking a anti-HTN medicine (beta blocker) and had slowly been weaned off of that prior to getting his shot as her cardiologist is afraid that it might affect the efficacy of the vaccine shot and had not been put back in any BP regulating meds until then and quite concerned because of her fluctuation BP. anxiety and gets to panic immediately, also is disabled and doesn't live with any nearby family, has allergies to alot of foods. State she comes from family of strokes, heart attacks, and high blood pressure and one of her biggest fears is having a stroke. States her boyfriend has a family of strokes too, 2 blood pressure medicines, which contain polyethylene glycol (PEG). and concomitant medications not reported. The patient stated after 1 week of getting the vaccine- getting sick, felt alot of extreme fatigue, felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it. On 03Apr2021 experienced severe headache which led her to stay in bed all afternoon, she also has a flu-like chills body ache symptom which comes and go. On 04Apr2021 experienced nausea and took Tylenol for feeling so sick and felt well 2 hrs after. On 05Apr2021 woke up feeling all the symptoms like the other days, her headache is more severe and describe it as she would like to shot her head because of the ache, she also had a sore throat and could not swallow or eat for 2 1/2 days, she also feel nauseous and throws up water already, she already was feeling dehydrated. After which she called her doctor and mentioned that no organization or her doctor cant guide her well with regards the symptoms that she is feeling if this is common after receiving the vaccine. She asked her doctor and her doctor said that it could probably be a symptom of COVID19 infection. So she got tested and turned out she had a negative result. After a while she also experienced some sinus pain that was not normal for her, she also mentioned that her face and eyebrows hurt. She went to her ENT and ENT who she trusted and respected a lot as a surgeon because according to her is very well versed mentioned that these are not normal side effects that she is experiencing. She also consulted with a brain surgeon and the brain surgeon mentioned that if the side effects won't go away , advised that she need to go to an ER and that doctor feared that he could be having stroke or meningitis. In shock, patient called her cardiologist again and cardiologist advised her not to be alarmed about brain surgeon's advised. She was back to her BP management medication for 2 days already and cardio advised that she should get the vaccine still. On Wednesday and Thursday- her sinus pain went away she had experienced the worst pain ever and had her gripping her pelvis because of the pain, she also have massive diarrhea, had nausea and throw up viscously that it is almost coming out of her nose and also went to sheer panic. Also felt that she almost faint, not dizzy not vertigo type for under a minute. Called her neighbor and neighbor said that she is not speaking well or understood well. She was profusely sweating and had whole body sweat drenched on the floor. Called her physician and physician said that it could be food poisoning. Patient even said that she is not blaming the above event with Pfizer. Also mentioned she experienced sore throat in between. Patient states she is losing her mind, she is a highly anxious and panicky person, she was worried about getting the vaccine at first, but went ahead with it. States she has removed herself from her blood pressure medication, Bystolic, because there is an ingredient in there that is a beta blocker, polyethylene glycol or polysorbate or something. Worried of having an anaphylactic reaction now after the vaccine to the medication, states she has allergies to alot of foods. Patient states she had a very painful arm at first, that she had no symptoms for the first four days, states a week later she started getting sick, states last Saturday symptoms worsened significantly, that she had a headache and it wouldn't go away for 4-5 days, nausea, vomiting a couple of days, dehydration, a little diarrhea, chills, mild body aches. One day she was down for the count, then on Easter Sunday she took a Tylenol and was better. Later in the afternoon the nausea came back. Woke up Monday morning and couldn't get out of bed, wanted to die. States her baseline temperature is 94.6 and she went all the way up to 98 it was rising, body aches, sore throat. Went and got tested for Covid, flu, and strep and were all negative at urgent care. There the doctor told her because of her neck pain that she says she has had for years, she could die of a stroke or meningitis and so she called her ENT and they told her to wait a couple days and then to go to the emergency room if she was not better and the headache does not go away soon. patient states she does feel better today, only last night she woke up with gut ripping food poisoning, like she had the flu, Had worst menstrual cramps in that area, then she was throwing up, had diarrhea, felt like she was going to faint, went into this ungodly sweat. Saw on news that more people are getting sick a week or more after the shot, did not mention which shot they received. States she has a previous disability and a broken foot. Today she is feeling fine, just still very tired. experienced side effects between 1-1.5 weeks after the injection. She listed the following symptoms: headaches, chills, nausea, a sore throat, fatigue, ice-cold ends, vomiting, and diarrhea. She specified her sore throat was from hell, her temperature was up, but she had no fever, and both the vomiting and diarrhea were little. She added last Saturday was when she felt sick the most and it lasted 4-5 days. She said she tested for COVID-19 and the Flu. She specified the doctors also thought she had a stroke then meningitis. She explained she spoke with 3 doctors but feels like she's on her own to determine whether she should get the second dose. The patient underwent lab tests and procedures which included body temperature: up, body temperature: 94.6, body temperature: 98, influenza: negative, sars-cov-2 test: negative, streptococcus test: negative. Seriousness was non-serious. The outcome of the events was unknown.

Tested positive for Covid 19; Low grade fever; Head cold; Little cough/lingering cough/cough; Sneezing; Slight headache; Very lethargic; I had a dull ache; Confusion, kind of foggy; Confusion, kind of foggy; Tiredness; sick; She slept for 15 hours; Could feel it in her teeth; Sinus infection; This is a spontaneous report from a contactable consumer (patient, self-reported). This 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6208 and expiry date was not provided), via an unspecified route of administration, in arm left, on 19Mar2021 at 13:10, as single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient reported that she got her first dose of the Covid 19 Vaccine on 19Mar2021, and she had side effects starting the night of 20Mar2021. That weekend she had all the side effects. She probably had Covid when she got the shot. She had all of the side effects, and they are the same side effects listed on the pamphlet. Her immune system is heightened, that's how her body reacts to it. Someone at work got Covid, and the patient tested positive for COVID on 31Mar2021 but it could be viral shedding. She was supposed to go for her second dose of the vaccine on Friday (09Apr2021) at 1 PM. She was better at this point, she still has a little cough from 25Mar2021. Her question is can she get the second dose on 09Apr2021. The Board of Health said she should go. She mentioned that she thinks she lost a half an inch as she was 5'5", she was shrinking. Patient had tiredness on 19Mar2021. Reported that her symptoms pretty much were tiredness. Her arms felt like they were 20 pounds, she was very lethargic on 20Mar2021. She had a slight headache and confusion, she was kind of foggy from 20Mar2021. A couple days after that, midweek she started getting a head cold and cough on 25Mar2021. She doesn't know if it was from the flu, a side effect, or Covid. She went to Urgent Care for her head cold on 27Mar2021 and they gave her a Z Pack and a medicine for cough. She still has a lingering cough. The Z Pack helped with the sinus infection. She tested positive after that. She is quarantining from (Name) and waiting to get her second shot. Stated that there was also a head cold going around her office, some people with Covid and some not. She doesn't know if this is a combo effect for her. She got the shot at 13:10 and went back to work, then she came home and went to sleep. She was tired the whole weekend. She didn't feel herself. Her head felt like a dull ache from 20Mar2021, maybe just foggy, she was not thinking clearly and was not herself. Really on Monday she went to work and still had side effects thinking it was from the shot because she was fine until she got it, but some people said she had Covid when she got the shot. It was reported that she had a negative Covid test that Sunday before. She gets a test every weekend so she can see her granddaughter. She has probably had 50 tests. She was very prone to negative tests, then all of a sudden after the vaccine everything was different. She doesn't know if it is Covid or a reaction to the vaccine. She had a positive rapid test on 31Mar2021, and the PCR on 01Apr2021 came back positive. They said it was viral shedding. She was starting to feel better. She was more tired than she usually is. Usually she only needs 3 or 4 hours of sleep. She works from home. She slept for 15 hours when she got off at 17:00, and she slept in. Now she sleeps a little more, probably what normal people sleep, so she is not as tired as she was. She is not back to 100 percent herself since she usually only needs 3 or 4 hours of sleep. She is tired at the end of the day. She can function and do her routine. She worked yesterday from 09:00 to 20:00. She came home and fell asleep. It is harder working from home with phone calls and emails, everything takes longer. She got it done and she can think straight. Most of her symptoms have subsided except for the cough, and even that is just here and there. It is not like she can't breathe or it hurts. Her headache is not bad, just a dullness that's gone. It was maybe 3 or 4 days through until Tuesday. Tuesday and Wednesday she was better and Thursday she got a head cold. She read that she can't get Covid from the vaccine, but it said all of these side effects could have come from the vaccine so she has no idea. The headache was like a fuzziness, a dull ache. She had sneezing on Thursday (25Mar2021) when she got the cold, then Friday 27Mar2021, she had a low grade fever. She went to Urgent Care on Saturday. At Urgent Care they didn't test her for Covid, but she had a 99.1 fever there and he gave her a Z Pack. They gave her some pills for the cough. They said the cough was from post nasal drip. She didn't know if it was or wasn't. Her lungs were clear, so they said the cough was from that. The Z Pack was from Saturday to Wednesday, it was a 5 day pill thing. She took her last pill Wednesday when she was taking the Covid test. She just has the cough now, she doesn't know if it was that or something else. The head cold went away Thursday or Friday. She doesn't know what the cough is from. She thought it was part of the cold and it started on Thursday. She didn't have a cough as a side effect, it started with the cold. She is nasally still, she can hear it. She had the fever maybe for a couple days, she could have had it and didn't know. She has recovered completely from it. She hadn't had Covid until she got the shot. It's been 3 weeks since she's been sick. She hasn't had any test other than the Covid test. She could feel it in her teeth. Outcome of the event Head cold was recovered on an unknown date in Mar2021, Low grade fever and Sleep excessive recovered in 2021, event Tiredness was recovering; the events Confusion, kind of foggy and slight headache were recovered on 23Mar2021: Event cough was not recovered; for remaining events outcome was unknown.

Immediately after the vaccines, I experienced severe flu-like symptoms. After the second vaccine, I also experienced a visual issue. Everything in my visual for appeared to be dusted in light gold on the second day after the second vaccine. Two months after the vaccine, I started to experience an extreme exhaustion. It has currently been 5 weeks now. Is this a side effect of the vaccine?

could not sit down; She could not sit down and sleep before; muscle pain in right leg, from right foot and traveled up to knee/It came on and off/the pain was unbearable/The muscle pain at first was on the right leg only and last night it was both legs.; Right arm soreness; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 63 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534) via intramuscular, administered in arm right on 25Mar2021 14:30 as single dose for covid-19 immunisation. Medical history included high cholesterol. She is pretty healthy. No vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Concomitant medications included pravastatin (40 mg tablet) for high cholesterol taking for 2 years and stopped since Friday (unspecified date); Vitamin D. After having the first injection at a hospital, patient did not feel anything, just a little right arm soreness (25Mar2021 14:30). But exactly a week after, on Thursday (30Mar2021), she started to feel muscle pain in her right leg, from right foot and traveled up to knee. It came on and off. She did not take any medication. But Friday (02Apr2021) it got worse, she took only one paracetamol (TYLENOL Arthritis PAIN 650 mg, Count size 24 caplet, Lot: SLA055, Expiration: Jul2023) and felt okay. On Saturday (03Apr2021) happened again, she also took one in the morning and at night. On Sunday (04Apr2021), she felt again in morning took 1 paracetamol and at night she took another one, the pain was unbearable. Next Monday (05Apr2021), she almost called 911 at 7pm but she didn't do it, her neighbor is a nurse for 46 years and she told her to take two paracetamol. Last night (05Apr2021), she took two. She could not sit down and sleep before (Apr2021). She was able to sleep. This morning she felt it again (06Apr2021), her neighbor told her to take 2 for 3 times or every 6 hours. She took 2 this morning. She is scared. She called her doctor. She was going to call 911 last night because the pain was bad and she was scared. The muscle pain at first was on the right leg only and last night (05Apr2021), it was both legs. She needs the right medicine. The doctor said she should call Pfizer and discuss. She wondered if it is okay to take second dose and what the right medication is to take to help with the pain. Patient did not visit emergency room. The patient assessed the report as serious. Outcome of muscle pain in legs was not recovered, outcome of other events was recovering. No follow-up attempts are needed. No further information is expected.

Mild flu-like symptoms; beginning with sleeplessness; headache; fatigue; waves of mild nausea; muscle/joint aches; muscle/joint aches; waves of muscle spasm in right groin area; This is a spontaneous report from a contactable Other Health Professional reported for herself that a 63-year-old Female (no pregnant) patient received 2nd dose of Pfizer COVID-19 vaccine BNT162B2 (lot/batch number: EN6201) at Left arm on 02Mar2021 at single dose for covid-19 immunization. Medical history was Fibromyalgia, Arthritis, Lumbar disc bulge. Allergies to medications, food, or other products: PCN, codeine, ephedra, gluten. Concomitant drug included Progesterone, estradiol (ESTROGEN), minerals nos/quercetin/thioctic acid/vitamins nos (EMERGEN-C), ergocalciferol (VIT D), zinc. No other vaccines within 4 weeks prior to the COVID vaccine. Historical Vaccine was 1st dose of BNT162B2 on 09Feb2021 (lot/batch number: EL9269) at Left arm for covid-19 immunization. Patient experienced Mild flu-like symptoms: beginning with sleeplessness, headache, fatigue, waves of mild nausea, muscle/joint aches and waves of muscle spasm in right groin area. All lasted less than 24 hours from 03Mar2021 02:00 am with outcome was Recovered. No treatment. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

Side effects that started with pain in arm where injected, then achiness in whole body, chills was sleepless that night. The next morning (4/25) felt very tired, no energy, overall felt sick with flu-like symptoms, and stomach ache. Fever up to 101.6F.

When I got out of bed the morning of 4/1/2021 at 8 am, I went to turn off my humidifier in my bedroom. In turning off the humidifier, I leaned slightly to the left, felt the vertigo, and fell down on the bedroom floor. I could not do anything to keep myself from falling. Though able to stand up and walk a few minutes later, the vertigo persisted for several days. I did not have another falling event; however, since then I have restricted my head movements to avoid re-triggering the vertigo. To this day, at times I feel at risk of re-triggering the vertigo when I move my head too quickly, though I have resumed my usual daily activities and exercise routine.

disoriented; confusion; weak/lack energy; facial and tongue numbness; facial and tongue numbness; dizzy and light headed; This is a spontaneous report from a contactable other HCP. A 63-year-old female patient (pregnant no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 02Apr2021 11:00 (Lot Number: EW0151) as single dose for COVID-19 immunization. Medical history included hypothyroid (long standing with no new meds), allergies to nkda. Concomitant medication included levothyroxine sodium (SYNTHYROID). On 02Apr2021 11:15 am, the patient felt disoriented, confusion, weak, facial and tongue numbness, dizzy and light headed, lack energy lasted 10 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse event. The outcome of the events was recovered on 12Apr2021. No follow-up attempts are needed. No further information is expected.

stomach abdominal cramping; Appetite decreased; like gassiness; back pain; she was so sick.; she has a rash about the size of a quarter at the injection site; temperature of 102 degrees/fever; tightness in her chest; She threw up five times; She felt nauseous; Nightmares; She started coughing; muscle weakness; Her arm is sore; She could barley lift her arms; very very weak; delirious; restless; her head was pounding; has been sleeping an enormous amount.; headache; restless; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm right on 12Apr2021 15:00 (Lot Number: EW0153) as single dose for COVID-19 immunisation. Medical history included Neuropathy, Blood pressure abnormal, and allergic to cats, dogs, and everything outside. Concomitant medications included clonazepam taken for neuropathy peripheral, start and stop date were not reported; captopril taken for blood pressure abnormal, start and stop date were not reported; cyanocobalamin (VITAMIN B12) taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 23Mar2021 15:40 (Lot number: EH6204, She has difficulty reading the handwriting, she stated that the second character H, may not be an H.) (at age of 63-year-old) in right arm for Covid-19 immunisation and she felt like she got hit by mac truck, she was that tired and She felt like she could hardly move. There was no additional vaccines administered on same date of the Pfizer suspect or prior vaccinations (within 4 weeks). On the weeks that she received the first and second dose of her COVID vaccine, she skipped getting her allergy shot that week. She normally got her allergy shots every week. Patient weight: 176-178 pounds. It was reported that the patient was fine after she received the second dose, until about 11:00PM on 12Apr2021. She started to get muscle weakness. She was delirious on Monday night (12Apr2021). She also felt restless on 12Apr2021. Her head was pounding on 12Apr2021. She felt nauseous on 13Apr2021, very very weak began on 12Apr2021 23:00 and had tightness in her chest on 13Apr2021. She has only thrown up three times in 50 years. She threw up five times on Tuesday, 13Apr2021. She started coughing Tuesday morning, 13Apr2021. She thought maybe she was coughing because she needed to throw up. She does not know why she is coughing. Over the past few days, she has stayed in her pajamas so she did not look for a rash. She noticed she has a rash about the size of a quarter at the injection site. She did not really pay the rash much attention since she was so sick. She has a rash about the size of a quarter at the injection site, She noticed it on 14Apr2021 whenever she took a shower and took of the band aid. Clarified that it is about the size of a silver dollar. There was also a knot. She began running a fever on 13Apr2021. Yesterday (14Apr2021), she had a fever of 102 degrees. She has been taking 2,000-3,000mg of Tylenol and it has not been helping her fever. Yesterday (14Apr2021), her temperature was the same, and her head was pounding. She was able to eat a little bit, she drank a lot. She has been sleeping an enormous amount from 12Apr2021. Last night (14Apr2021) her temperature was at 100 degrees. It started to come down, before she got up. She normally does not sleep eight hours a night. She has been sleeping more than eight hours. Before she got up out of bed this morning (15Apr2021), she checked her temperature and it was 98.6 degrees. She knows that most people do not consider that a fever, but for her that is. Her temperature is usually 97 something degrees. 98.6 degrees is still sick to her. She was going to work from home today (15Apr2021), but whenever she sat at the keyboard to type, she could barley lift her arms. She could barley lift her arms began about 11:00PM on 12Apr2021. She has not tried to work. She still has a bit of a headache, and her fever broke, so she thought she could work today (15Apr2021). She felt extremely weak. Her stomach was cramping. She drank some tea, and ate a banana. She would describe it as stomach abdominal cramping. She was not expecting to feel this way. Her arm was still sore. Her arm was sore began about 11:00PM on 12Apr2021. She was going to see her doctor next week for a semi annual check up appointment.She was restless all day yesterday (14Apr2021). She has a back back, and has back pain. Whenever she has muscle weakness, her back is bad, and makes her hurt every where. Yesterday (14Apr2021), she was still restless and could not sit still. It is better today (15Apr2021), but has not gone away. On the morning of 13Apr2021, she felt nauseous. Now she feels a different type of nauseous. Before the nausea was in her chest, she thought she was going to have a heart at-tack. She called her husband at work, and asked him to come home because she was so scared. Whenever she threw up, it relived the pressure in her chest. She vomited four times and it gave her immediate relief. She vomited one more time later that evening after trying to eat some chicken broth. She just drank liquids after that. Nauseous intestinal: It feels more intense today (15Apr2021). It feels like it is moving down. Clarified that this is the same feeling as stomach abdominal cramping. She has issues with IBS, and diver-ticulitis. But this is different. She has not eating anything. With IBS, it is eating and the diarrhea. This is more like gassiness. She has had bowel movements, they are more intense with abdominal con-tractions. Very weak: Began about 11:00PM on 12Apr2021. She knew that night that she was not going to be able to go to work the next day. It is better. She thought that is was resolved this morning (15Apr2021), but then she could not get up the stairs. Her office is upstairs. Whenever she got to her office, she lifted her her arms to type and it was hard for her to hold her arms up. She has been sleeping an enormous amount: She did not do anything but drink, use the bathroom and sleep on 13Apr2021. Whenever she was sleeping, it was not a good sleep. Her temperature was 102 degrees, and her head was pounding. She was having nightmares. She was in a constant state of dreaming that she could not get out of. She still has been sleeping a lot. She has been trying to walk around. She put on a lidocaine patch, and is wearing a back brace. She was sleeping less than she was but it is still an enormous amount for her. She normally sleeps about five to six hours a night. The events did not result in emergency room visit or physician office visit. Therapeutic measures were taken. The outcome of events muscle weakness, restless, 'Her head was pounding', Weakness, cough, was recovering, of delirious was recovered on 14Apr2021, of 'tightness in her chest' was recovered on 13Apr2021, of nightmares was recovered on 14Apr2021, of other event was unknown.

Chills; Fever; Muscle soreness; Diarrhea; Nausea; I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life; I kept thinking everyday will get better and it's just haven't; Anatomical site of administration-The consumer stated, "On my shoulder, left shoulder."; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left shoulder on 26Feb2021 (Lot Number: EL3247) as single dose (at 63 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included curcuma longa (TURMERIC [CURCUMA LONGA]), colecalciferol (VITAMIN D 3). Previously the patient received the first dose of BNT162B2 (Lot Number: EM9810) on 05Feb2021 in the left shoulder for COVID-19 immunisation. On an unspecified date (as reported), the patient experienced chills, fever, muscle soreness, diarrhea, nausea, I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life, I kept thinking everyday will get better and it's just haven't. Therapeutic measures were taken as a result of diarrhea included antidiarrheal. The outcome of the events was unknown (as reported). The consumer stated, "I had my Pfizer second shot on 26Feb2021 and I had chills and the fever and sore muscles and about four days later I started having Diarrhea, nausea and I had it the entire month and I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life". Anatomical site of administration, the consumer stated, "on my shoulder, left shoulder". No follow-up attempts are needed. No further information is expected.

Later that night, on 1/27/21, I felt sick, Nausea, muscle soreness. Next day 1/28/21 went to work with headache, couldn't lift my arm up very swollen. Felt sick got worse felt very hot. Temperature of 104, got sent home from work. Took Acetaminophen and 2 cold tablets fever went down to 101.9. Took cough syrup. Went to sleep. got up next norming arm still very swollen, went to work got sent home no fever but still felt bad, achy muscles and arm still swollen. Stayed home in bed whole weekend. Got headache every day including Monday morning when got up to go to work. Headach on Tuesday also. Felt better on Wednesday. Woke up with headache on Thursday. Woke up with a headache on Friday.

she actually feels like she has covid; she actually feels like she has covid; felt like her head was in a tunnel/surround sound in her head; she was scared to death; ringing in her ears; diarrhea; nausea; ear aches that make it feel like her hearing is off; the vaccine may have poked her in the bone; temperature and it has been pretty normal for the most part and went up to 99.9 degrees Fahrenheit; felt like I wished I were dead; sick; tired; This is a spontaneous report from a contactable consumer (the patient). A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318; Expiration Date: 2021), via an unspecified route of administration, on 09Apr2021 at 14:30 (at the age of 63-years-old) as a single dose in the right arm for COVID-19 immunization. The patient's medical history was not reported. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EP69556121) on 18Mar2021 (at the age of 63-years-old) as a single dose in the right arm for COVID-19 immunization. There were no concomitant medications. The reporter state that exactly seven (7) days after her second dose, she "felt like I wished I were dead." She reports having diarrhea and nausea that she is still struggling with, and also reports ear aches that make it feel like her hearing is off, describing it as an echo "like I'm in a tunnel or buried in the sand." She reports that this "head thing" was so severe in the beginning and reports that it is still ongoing. She states she couldn't even stand to hear the television and reports that it felt like there was a "surround sound" in her head. She also reports that she just wanted to lay in bed one afternoon and when she woke up the next morning, she was still tired. She reports now that she is progressively feeling "some better" and thinks in 3 days that it will be gone, but she also believes that she may have COVID-19 now and feels like the 2nd Pfizer Vaccine actually bred the disease in her for some reason and she wished she was dead for three days. She also stated that she has spoken with her HCP about this who suggested she visit an urgent care; however, the caller states she cannot drive and has no means of transportation to this appointment. She continued to say that the symptoms were horrible and she is still going through it; states last night she was scared to death and she does not drive or she would have taken herself to the emergency room. She stated that she still had the ear ache, it is not so "echoey" but she still hears some of the ringing in her ears. The other thing concerning happened yesterday - she has also been monitoring her temperature and it has been pretty normal for the most part and went up to 99.9 degrees Fahrenheit and she has been trying to get ahold of someone to report this. States last night was the worst night with diarrhea and she was up and down all night long. The patient also mentioned that her second dose of the Pfizer Vaccine was in her right arm and the woman who gave her the vaccine may have poked her in the bone and caused her to jump. The patient experienced that she actually feels like she has COVID on an unspecified date with outcome of unknown, felt like "I wished I were dead" in Apr2021 with outcome of unknown, the vaccine may have poked her in the bone on 09Apr2021 with outcome of unknown, diarrhea on 16Apr2021 with outcome of not recovered, ear aches that make it feel like her hearing is off on 16Apr2021 with outcome of not recovered, tired in Apr2021 with outcome of recovering, felt like her head was in a tunnel/surround sound in her head on 16Apr2021 with outcome of recovering, nausea on 16Apr2021 with outcome of not recovered, she was scared to death on 16Apr2021 with outcome of not recovered, ringing in her ears on 16Apr2021 with outcome of unknown , temperature and it has been pretty normal for the most part and went up to 99.9 degrees fahrenheit in Apr2021 with outcome of unknown and sick in Apr2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 99.9 degrees Fahrenheit on Apr2021.

Overwhelming fatigue and achiness for 48 hours. Ibuprofen eased achiness but fatigue was so severe, I missed a day of work.

very fast heartbeat very high blood pressure at onset low blood pressure next day and after difficulty breathing arm pain and can't raise 45 degree trouble sleeping dizzy very very weakness can't open eyes nose bleeding a lot difficulty sitting difficulty chewing food brain fog and confusion muscle joint pain yellow face and palm congestion and running sneezing nose lost smell and taste it's been more than 5 weeks still can't recover most of the symptoms seems like damaged a lot can't do as heavy physical activities and house work lot more food to keep up the energy

meaning fever and chills; meaning fever and chills; felt generally terrible; Diarrhea; cough/dry cough; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248), via an unspecified route of administration on 26Jan2021 (at an age of 63-years-old) as single dose for covid-19 immunisation. Medical history included covid-19 from 23Dec2020 (23Dec2020 she tested positive for Covid-19). There were no concomitant medications. The patient previously took bnt162b2 (batch/lot number: EK9231) and experienced chills, fever, arm hurt real bad. On an unspecified date the patient experienced meaning fever and chills, felt generally terrible. On 28Jan2021, the patient experienced cough/dry cough. Caller reported that she is a healthcare worker and just retired. She clarified that she is a Dietician. She called yesterday and reported the fact that she had COVID in Dec2020, after having COVID, she had both doses of the Pfizer Vaccine. Second dose this week. She had Adverse reactions to both doses, meaning fever and chills. Yesterday, she started with a cough. She wants to make sure that this is all reported correctly. When she talked with someone yesterday and talked with someone who's accent she could not understand. Not hearing that any coughs were supposed to be a potential side effect of the vaccine. Patient had the first vaccine on 05Jan2021, Lot EK9231, and the 2nd dose on 26Jan2021, Lot EL3248. She had it at the (State name). Yesterday, she had 1 episode of Diarrhea and this morning another episode of Diarrhea. The cough started yesterday and that is biggest concern. She has not been able to see where it was a noted side effect. She spoke to nurse in Pfizer Drug Safety yesterday and then he put her through to next department and that is where she wanted to find more about if there has been any research or if there is in fact an association with the cough. She is now concerned because she again started to develop a dry cough today and wanted to know if this is something she should be worried about since she previously had Covid last Dec2020. "How long will it last?". The patient did not receive any treatment for the events. The clinical outcome of the meaning fever and chills (fever) was recovered on an unspecified date in 2021. Clinical outcome for cough/dry cough, meaning fever and chills (chills), felt generally terrible, diarrhea were unknown. Follow-up attempts are completed. No further information is expected.

Woke up in the middle of the night and couldn't breathe. Couldn't walk and talk at the same time for 3 days. Had no energy because it was too hard to breathe. Was put in the hospital for 3 days, checking on lungs and heart. Had chest X-rays etc. Could not come up with definite reason, but my condition did not improve. I was put on 2 liter of oxygen (which I was never on prior to shot), and told to see doctor in 7 days.

Dizzy; Headache/ sick headache; I have been in bed ever since/I can't turn my head or anything; it got worse today; Sick; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 63-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 27Jan2021 (age at vaccination was 63 years) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included anxiety. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for anxiety. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE for COVID-19 immunization. The consumer stated that she had been sick since yesterday. She was at work and got dizzy and had a headache. She took like for the headache, she had like a sick headache at night and she took Tylenol (Lot no: E2392V, Expiration date: 20/22) but it seemed like it got worse today. She had a second shot of the virus shot and she had been in bed ever since. She felt very dizzy. She couldn't turn her head or anything, so she went to urgent care and they told her to call them right away that they thought that might be it was an allergic reaction. (As consumer was sure, hence allergic reaction not captured as event). The consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department and provided with the website link as (Website provided). The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

5-4-21 about 6 hours after shot, I had an extremely sore left arm and tenderness under the left arm pit. Beginning about 7 hours after shot, I had chills, fever of 100.2, migraine headache and lower back pain. Did not sleep at all through the night. By morning on 5-5-21, all symptoms still present plus feeling dizzy, light-headed and nausea. Stayed in bed all day. By 6 pm on 5-5-21 (27 hours after shot) I had a fast heart rate and heart palpitations. By 8 pm, I had a tightness and pain in my chest. Difficulty breathing, although that may have been my trying to alleviate some of the pain.

hypoglycemic shock; positive for covid 19; mobility issues; gets out of breath easily; weak; couldn't remember anything which wasn't normal; WBC was elevated; headaches; went sky high into the 500s and they couldn't control it in the hospital; viral pneumonia; renal failure; Her blood sugar was 28; Covid fog; was not eating or drinking; throw up; This is a spontaneous report from a contactable consumer or other non-health care professional (patient daughter) via Pfizer. A 63-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, Batch/Lot number was not reported and expiry date unknown) via an unspecified route of administration on 25Mar2021 (at the age of 63-year-old) as 1st DOSE, SINGLE for covid-19 immunization. Patient took vaccine as she wanted to fly on an airplane and not worry as heavily. Medical history included ongoing diabetes mellitus, patient had diabetes for at least 5 years, ongoing high blood pressure from an unknown date, reporter think patient high blood pressure was more with her weight because patient was obese. Patient was immunocompromised with her diabetes. Patient had no relevant family medical history. Concomitant medication included ongoing metformin (METFORMIN) taken for diabetes mellitus. Patient has been on it for years. Reporter believed she was on the max dose that she thinks was 2000mg, but could be wrong. Patient was not eating or drinking from 03Apr2021 and did throw up. On 06Apr2021 patient was tested positive for Covid and experienced hypoglycemic shock at 11:00, renal failure and Covid fog. Reportedly, patient also experienced viral pneumonia, mobility issues, gets out of breath easily, weak, her blood sugar was 28, covid fog, couldn't remember anything which wasn't normal, wbc was elevated and headache. The patient was hospitalized for hypoglycemic shock and COVID-19 from 06Apr2021 to 17Apr2021 (11 days), then discharged and was told by her HCP to wait 8-12 weeks before getting second dose of Pfizer covid vaccine. Patient scheduled to receive second vaccine dose 15May2021. Reporter was told that it was a max of 42 days that patient can get the second dose of the vaccine, but that has obviously since passed. They want patient to come in and get a second first shot. When patient was admitted, the doctor thought patient had viral pneumonia already for at least a week, so it would have started about when she got the shot. Patient was better, she was not on oxygen anymore, but she still gets out of breath easily. Patients mobility issues started when she came down with symptoms. Patient had renal failure and was weak. Patient was not eating or drinking. Patient was diabetic and she had hypoglycemic shock which was what put her in the hospital. Reporter thought it was probably a cold or flu or something and Easter happened where she was not hungry and did throw up. Reporter thought it was something she ate that was bad. When she had the hypoglycemic shock reporter could not wake her and patient was in some kind of unresponsive state from 11:00 to about 15:45. Patient blood sugar was 28 when the paramedics arrived. They were able to get her responsive and transferred her to the hospital. They ended up putting her on a dextrose drip because they could not keep her blood sugar up. They put her on steroids and the number went sky high into the 500s and they could not control it in the hospital. There was a lot of stuff that happened. Reporter did not believe that patient has any lasting effects from the hypoglycemic shock. Patient sugar was back to normal and she was on her normal medications. Patient was off insulin which they gave her in the hospital, so that part was okay. Patient was dealing with Covid fog also. Reporter does not know if it has to do with blood sugar or how the virus attacks the body. Patient had multiple MRIs because they were worried, she had a stroke, and she said she could not remember anything which was not normal. Patient not eating and drinking started right before Easter and was much better. Reporter believed that at about 14Apr2021 or so patient started to eat better and have more of an appetite for food. Patient has recovered completely. The reporter did not notice the Covid fog until her mother was in the hospital on 06Apr2021. She does not remember her first week in the hospital, and then even when she was discharged on 17Apr2021 that whole next week she was still very foggy. The reporter would say she was better now. patient talks normally and was back to swearing which is perfectly her. Patient has recovered completely at this point. Patient mobility was better. Patient was not using the walker in the house today, and her balance was better. It was probably due to some of the side effects of the medicines they added like a beta blocker and other things to make sure she was okay. Regarding kidney failure started, reporter stated on 06Apr2021 patient creatinine was 3.99. Patient also had a high D dimer and were worried about her clotting and throwing a PE or something. That was mostly in the first few days around the 6Apr2021, 7Apr2021, 8Apr2021, 9 Apr2021, 10Apr2021 when they were not sure what was going to happen. The following week patient was still at 5 to 6 liters of oxygen, but by Friday night 16Apr2021 she was down to 1 liter of oxygen. Patient did not come home on oxygen. Reporter believed patient kidneys have recovered, but she did not know. The patient underwent lab tests and procedures which included blood creatinine: 1.47 on an unknown date, 0.97 on Sep2020, reporter does not know if it returned to 0.97, but the last number she knows of was 1.47, 3.99 on 06Apr2021, blood creatinine: 1.47 on 17Apr2021. Patient had normal bloodwork in Sep2020 and her creatinine was 0.97. Reporter did not know if it returned to 0.97, but the last number she knows of was 1.47. That would have been when patient was discharged from the hospital. Blood glucose: 500s on an unknown date in Apr2021, blood glucose: 28 on 06Apr2021. On 06Apr2021 patient was tested positive for Covid. On an unknown date patient got CT, high d dimer, CBC, MRI, metabolic function test, white blood cell count, X-ray and Chem 28. Reportedly, bloodwork were done daily in the hospital, and patient has had bloodwork once since she was discharged. WBC was elevated so they did a blood culture to make sure patient did not have an infection. The culture was negative. There were no additional vaccines administered on same date of the Pfizer suspect. There was no prior vaccination within 4 weeks. There were predisposing factors diabetes and immunosuppression. Patient started Tylenol pill on 06Apr2021 after vaccination at an unknown dose. They gave it to her continuously because she had bad headaches. They started her on antivirals and took her off of Remdesivir because of her kidneys. They put her on a different antiviral that the reporter did not remember the name of and a biologic. Home health just discharged patient, and she was still dealing with viral pneumonia and mobility issues. Patient was still on different medicines and she normally was not. The report is related to study or programme. The outcome of the event hypoglycemic shock was recovered on 06Apr2021 and was not eating or drinking was recovered on 14Apr2021, viral pneumonia, mobility issues, was recovering, renal failure, positive for covid 19, gets out of breath easily, weak, her blood sugar was 28, went sky high into the 500s and they couldn't control it in the hospital, covid fog, couldn't remember anything which wasn't normal, wbc was elevated, throw up and headaches was unknown. Follow-up attempts are completed; information about lot/batch number cannot be obtained

/the swelling of her knees had diminished greatly; She was quite swollen; She could feel it a little bit in her shins and ankles, however that pain was not acute, she just felt discomfort.; Sore/ she woke up in agony.; She was up all night Friday night and didn't get any sleep at all; Acute bilateral knee pain/ She could feel it a little bit in her shins and ankles, however that pain was not acute, she just felt discomfort.; She began to feel discomfort in her knees; This is a spontaneous report received from contactable consumer, the patient. A 63-year-old adult female received the first dose of intramuscular BNT162b2 (solution for injection; Lot EW0175 and expiry information not provided) as a single dose in the right arm on 06May2021 at 11:40 (at 63-years-old) for COVID-19 immunization. Relevant medical history included Stage IV cancer survivor, mastectomy with removal of lymph nodes (Feb2020-Feb2020), radiation treatment Apr2020-May2020, infusions (ended in 2020), Breast reconstruction with first Tram flap breast reconstruction 05Apr2021 and Full-blown TRAM flap with muscle and fat from abdomen added to breast 13Apr2021, and pain. Concomitant medications included trastuzumab (HERCEPTIN) from unspecified date for unspecified indication; pertuzumab (PERJETA) from unspecified date for unspecified indication; and hydrocodone bitartrate, paracetamol (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) from 20Apr2021 and from 21Apr2021 for pain. The patient previously received prophylaxis with the flu shot, and the tetanus vaccine with which she experienced sore. The patient reported that she received her first dose of the COVID-19 vaccine on Thursday, 06May2021. The next day, 07 May 2021, she woke up in agony with her knees, the pain was acute, she could hardly bare weight. She confirmed the pain was in her knees, but at times she could also feel it a little bit in her shins and ankles, She did try and treat the pain on Friday during the day, maybe about noon on Friday, she took some over-the-counter ibuprofen 200mg. The patient reported that she does not have pain usually, though was shocked when she took two ibuprofen 200mg tablets and the ibuprofen did not even touch the pain, it had no effect whatsoever. The patient re-iterated that she was administered the first dose of the COVID-19 vaccine on 06May2021 at approximately 11:40AM. Then, the nurse came by, spoke to her, and released her to leave at 11:50-11:55AM. At around 8PM that evening, she began to feel discomfort in her knees. She did not think much of it just through reading info about side effects including achiness and so forth. She went to bed and she slept through the night, which she does not always do. The next day, on 07May2021, she woke up in agony. The patient mentioned that prior to the vaccine, she had been through so many surgeries, so she has a high pain tolerance. The patient explained that she does not even take the pain medication they send home with her. But, with her knees, the pain was acute, she could hardly bare weight. She confirmed the pain was in her knees, but at times she could feel it a little bit in her shins and ankles too, however that pain was not acute, she just felt discomfort. The patient stated that she was up all-night Friday and experienced the pain all day Friday. She told herself to just deal with it and that the pain would get better since she read side effects would dissipate in a couple of days. However, the pain did not, and she was up all-night Friday night and did not get any sleep at all. Saturday morning, on 08May2021, she went to the emergency room (ER). She was seen by an ER physician who immediately put her on IV morphine and steroids and after that, maybe thirty minutes, the pain started easing. She later clarifies she was put on IV dexamethasone and then morphine and ondansetron, stating "maybe that was to wake me up". Caller confirms she has no NDC, Lot number and expiry date for these medications. She confirms she was not admitted into the hospital, she was only there for a couple of hours and then released home with a five-day pack of prednisone. The ER doctor mentioned his colleagues have seen something similar but usually with the second dose. caller explains when the ER doctor examined her, he could see she was quite swollen. She confirms the ER doctor diagnosed her with "acute bilateral knee pain, adverse effects of the COVID-19 vaccine". She came home from the ER and did get some rest. It was to the point now, yesterday she walked around the house and she was not in acute pain at all. She could tell the swelling of her knees had diminished greatly. However, there is still some movement that was uncomfortable, but it was not acute; She confirmed the pain has improved. The patient reported that she did have blood work done in the ER on 08May2021 including C-reactive protein, complete blood count (CBC) with platelet differential, and a comprehensive metabolic panel though results were unknown. The outcome of the events quite swollen/swelling of her knees, sore/ she woke up in agony was recovered on an unspecified date in May2021. The outcome of the events knee pain, discomfort in her knees, feel it a little bit in her shins and ankles, felt discomfort, was recovering. The outcome of the event did not get any sleep at all was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Brain fog... It continued for 3 days and I could not drive. However, it continues now to a lesser degree with light headedness and loss of balance

In about three days from the first injection I had loud tinnitus 24/7 in both ears. Could not find anything online about it. Considered not getting second injection but one family member had died from the virus. Saw a dioctor for sinus issues and worse tinnitus. He said he had heard others complain about it after the shot. No known treatment. It was getting more difficult to concentrate and focus. Also I had to ask my daughter to repeat some words when we were in the same room. Went to an audiologist for testing. Qualified for hearing aids. Healthcare provider said patients were complaining of worse tinnitus after shot. Previously I had occasional low noise tinnitus, off and on for more than ten years from Betaseron injections years ago. I reported to Pfizer directly about 24/7loud tinnitus. Saw my primary doctor to report it and see if he had heard of any treatments. About May 25thmy right ear had a sudden sharp, piercing sound for a few seconds. A day later it seems the tinnitus is now only in the left ear, or the right ear is much more mellow in tone compared to the left ear. Filled out Vsafe report to the CDC.

She felt a burning sensation whenever the covid vaccine went in; muscle pain all over, her muscles felt achy; Tiredness; could not eat; pressure in her ear is from swelling; pressure in her ear is from swelling; throat tightness; could not sleep that night; muscle tightness started in the shoulder/shoulder muscle got tight/tightness went to the back of her neck, then to the front of her neck; hurting so bad; Under her chin, on both sides, there are swollen lumps; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 27Mar2021 at 13:00 (Batch/Lot Number: ER8734; NDC & Expiry date: unknown) (at the age of 63 years old) as 1st dose, single for COVID-19 immunization. Patient took Pfizer COVID vaccine because of her job. She works with the public at a public library. History of all previous immunization with the Pfizer vaccine and additional vaccines administered on same date of the Pfizer suspect were reported as none. Medical history included acid reflux for years, colitis, bad sinus issues for several years and COVID-19 diagnosed on 04Jan2021. Part of her sinus issues, is that her sinuses block up and stuff drips down the back of her throat. Whenever she had COVID in Jan2021, the main thing that bothered her was a terrible sore throat. Whenever she had COVID, she went to an urgent care and the doctor told her that her throat was swollen bad. She kept spitting phlegm out in the toilet, and the doctor told her if it got any worse, she may need to go to the hospital, if her throat is starting to swell closed. The urgent care doctor prescribed her a steroid, and she took that for a week. She has a bad right shoulder; it aches all of the time. She does not like going to the doctor, so she has not had it checked out. She has frozen shoulder in both of her shoulders. She clarified that she had shoulder issues before receiving the first dose of the COVID vaccine. She constantly has neck pain. It is normal for her to have aches in the back of her neck. The pain from her shoulders goes into her neck. Patient reported that there was this thing that runs in her family. She has never been tested for it. It is a disease. Her mom and dad do not think that she has it. She thinks that is called Marie Toothe disease. Concomitant medications included fluticasone propionate (FLONASE) for bad sinus issues, famotidine for 2 years for acid reflux, and has been taking mesalazine (LIALDA) for years for colitis. She takes Flonase pretty much daily in the summer. She stopped taking during the winter. She started taking it again a couple of months ago. She started back taking it whenever things started blooming. Patient reported that she got hives from a flu shot. Flu shot name, NDC, lot number and expiration date were unknown. Hives after a flu shot happened five years ago, she has not gotten a flu shot since. On an unspecified date, the patient called to report reactions. She was concerned about getting her second dose of the COVID vaccine. Patient's weight was between 110 and 120 pounds. She was diagnosed with COVID on 04Jan2021. Because of COVID, she lost weight, she got down to 110 pounds. Now she is putting weight back on and getting back to her regular size of 120 pounds. She lost a bunch of weight whenever she was sick with COVID. She has been trying to call the CDC but has not been able to get through to speak to anyone. She received the first dose of the COVID vaccine in her left arm, because her left arm is normally better. She received the first dose of the COVID vaccine at 1:00PM. They made her sit around and wait for 30 minutes because she has had flu shot reactions before. She waited the 30 minutes and felt okay. Then she noticed at dinner time, about four or five hours after the first dose of the COVID vaccine that she was feeling muscle pain all over, her muscles felt achy. After she got the first dose of the COVID vaccine, she felt like COVID was coming back into throat. At supper time, she could not eat because of throat tightness. She had to eat soup and could not take one of her big pills: Began probably about four to five hours after receiving the first dose of the COVID vaccine. Her throat has been doing this weird thing where it feels better, and then feels tight again. It is back and forth. Right now, it is better. This Saturday, she was supposed to get her second dose of the COVID vaccine. She is worried that her throat will swell up worse. She is asking if she should get the second dose of the COVID vaccine. About one week before receiving the first dose of the COVID vaccine, her throat was sore and bothering her. She went to urgent care on 22Mar2021. She had COVID in Jan2021, her throat has gone back and forth like this. At urgent care, they did a COVID test on her and it was negative. They also did strep test on her and it was negative. The doctor looked at her throat and said he did not see anything. The doctor did not really want to look in her throat. The doctor was worried she may have COVID, so he only took a quick look. She felt like muscle tightness started in the shoulder when she received the first dose of the COVID vaccine. Her shoulder muscle got tight, then the tightness went to the back of her neck, then to the front of her neck. She also had pressure in her ear on that same side; she clarified that pressure was behind her ear. She thinks the pressure in her ear was from swelling. Shoulder tightness, back of neck tightness, front of neck tightness, and pressure behind her ear all happened at the same time. She was hurting so bad. The tightness and pressure come and goes. She is starting to wonder if wearing a mask is causing this. She wears two cloth masks at work. She does not like wearing medical grade face masks because she feels like she cannot breathe. After work, she will come home, and her throat will be a little sore. She was asking if there are lymph nodes in her throat. Under her chin, on both sides, there are swollen lumps. The left side was worse. She put ice on it, and it felt better. Began on 27Mar2021, she could not sleep that night which was weird because it comes and goes. Whenever it comes and goes, it was probably not as bad as the day that she received the first dose of the COVID vaccine. It still hurts. She was asking if this is an immune inflammatory response. She was supposed to get her second dose of the COVID vaccine this Saturday. She is freaking out about it. Everyone has told her that the second dose of the COVID vaccine is worse than the first dose. She was asking if they can give her the second dose of the COVID vaccine in her thigh instead. She is worried that if she gets the second dose of the COVID vaccine in her thigh, that she will not be able to walk after. The adverse events did not require a visit to the Emergency Room/Physician Office. She is thinking about going to see a doctor. The night that she received the first dose of the COVID vaccine, she thought to herself that if she got any worse, she would go to the emergency room. She was close to going to the emergency room. There were no prior vaccinations (within 4 weeks). The outcome of the event burning sensation was recovered, muscle pain was recovering, tiredness was not recovered, while for the other events was unknown. No follow-up attempts are needed. No further information is expected.

a low grade fever; worried; emotional basket case; she experienced emotional side effects stating she felt paranoid and was crying.; she experienced emotional side effects stating she felt paranoid and was crying.; Body temperature running 2 degrees high; Headache; Arm site injection pain; Broke out into a couple of drenching sweats; This is a spontaneous report from a contactable consumer. A contactable 63-year-old female consumer(patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0186) via an unspecified route of administration on 21May2021 on left arm as a single dose for COVID-19 immunization. The patient's medical history included Asperger's syndrome (From: Unspecified To: Ongoing), she was diagnosed with Asperger's at age 57 and has had this type of reaction with other drugs and foods in the past. She says she has taken antidepressants in the past which caused this type of reaction which included having suicidal thoughts. She had history of high blood pressure (From: Unspecified To: Ongoing) since she was 32 years old. The patient reported that she developed high blood pressure during pregnancy with her first child. She reported that she was never given a chance by her physician to see if her blood pressure would recover on its own after pregnancy, she just put on blood pressure medications, penicillin allergy (From: Unspecified To: Ongoing), she was overweight and had depression and suicidal thoughts with certain medications (From: Unspecified To: Unspecified). The patient reported that almost all antidepressant drugs and certain pain killers for arthritis caused her to have depression and suicidal thoughts. She did not provide details regarding which medications caused her to experience depression or suicidal thoughts. She had sensitivities to medications (From: Unspecified To: Ongoing). She reported that she cannot take any generic form of Imitrex, she can only take the brand name. Also reported that the medication sensitivity runs in her family. Her daughter was allergic to penicillin and had a moderate to severe reaction to the pertussis vaccine at 6 months old. The patient reported that her daughter could not take anything with the ingredients in that vaccine. She reported that her mother also almost died from anaphylactic shock from a penicillin drug. The medication sensitivities run right down the female family line. She did not provide details for medication that resulted in her mother's anaphylactic shock. The historical vaccine of the patient included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0167) via an unspecified route of administration on 30Apr2021 on left arm as 1st dose, single dose for COVID-19 immunization. It was reported that the patient did not receive any prior Vaccinations (within 4 weeks): and did not report any adverse events following prior vaccinations. The concomitants medications included lisinopril and hydrochlorothiazide (Start: Unspecified Stop: Ongoing). The patient reported that she has been taking lisinopril and hydrochlorothiazide since she was 32 years old for blood pressure. The patient reported that she was aware of all the side effects and everything, and kind of knew what to expect. After the second dose on 21May2021 caller reported that much to her surprise at 21:00 hours, her physical side were extremely mild. Body temperature running 2 degrees higher at 98.8 or 99.2 and she still felt ok. She reported that her body temperature normally runs a little low, 97.2 degrees F or 97.6degrees F. The same day she experienced arm site injection pain, she applied Aspercreme and CBD oil. The same day patient also experienced headache. She reported that she does not have a primary care physician. She was drenching sweat she experienced told her that she was running a low-grade fever. She reported that the elevated temperature continued through the night and into the morning of 22May2021. She reported that her body temperature returned to normal after she had the second episode of drenching sweat around 2:00 PM on 22May2021. She reported that she was done with the paranoia and was worried about if the paranoia was coming back, she would not think it was funny. She reported that she got the Covid-19 vaccine because she does not have health insurance and she is also 63, overweight, and has high blood pressure. She stated why would you not get the Covid- 19 vaccine if there was no charge for it and it could save your life and keep you out of the hospital. She stated that the pros of the Covid-19 vaccine outweigh the cons. She does not want other people that have the same issues with the Covid-19 vaccine affecting their mental health to get caught by surprise and think that it was permanent. She woke up the next morning on 22May2021 and did not even think about the arm pain. All the physical stuff was a walk in the park. She did not expect and what took her by surprise was that she was an emotional basket case on the morning of Saturday, 22May2021. She reported that she has had this side effect with various other drugs in the past. At first she did not put two and two together because thats how far removed it has been since she had this reaction to the other drugs. She inquired if becoming an emotional basket case was a known side effect of the Covid-19 vaccine and inquired if mental impact of the Covid- 19 was part of the study and if mental health questions were part of the surveys completed by patients. She reported that emotional changes for her can be associated with certain medications that she takes. She reported that antidepressants in particular will send her into a tailspin. She was encouraged to continue taking antidepressants in the past but stopped when she began feeling suicidal. She did not provide product details for the antidepressants that she experienced adverse events with while taking. She reported that she was basically on a 100% raw organic diet. After she had the second episode of drenching sweats, all of her side effects left. She stated that people may want to know that mental side effects of the Covid-19 vaccine are temporary and that it might happen. On 22May2021, she experienced emotional side effects stating she felt paranoid and was crying. She stated that this had been reported or evaluated for in the trials. The outcome of the events was crying, a low-grade fever and worried was unknown and rest of the events recovered on 22May2021. It was reported that the patient did not require emergency room or physician office visit. Information on Lot/Batch number was available. Additional information has been requested.

severe headache, between the eyes, worsened; very bad cough, she woke up with it, its hard to breathe with the cough, worsened; very bad cough, she woke up with it, its hard to breathe with the cough, worsened; yesterday she was tired when she got her shot, yesterday morning she slept all day; she was not really hungry; yesterday she was tired when she got her shot, yesterday morning she slept all day; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 at 11:00 hours, as single dose (at the age of 63-years-old) for covid-19 immunisation. Patient had no medical history. Patient stated that she had no problems, no medications, no heart problems, no diabetes, she was free and clear of medication. Patient had no family medical history relevant to events. Patient stated that a couple family member been vaccinated, and they did not had a problem. The patient's concomitant medications were not reported. Patient had no prior vaccinations (within 4 weeks). On 07Apr2021, patient got her shot at 11:00 hours and patient were tired when she got her shot and in morning patient slept all day, she did not eat because she was not really hungry, she had a headache between the eyes and it was odd for her to not be hungry. Patient stated that it happened after the first shot. Patient had severe headache and cough happened in the middle of the night, and can't breathe (on 07Apr2021). Patient had a bad cough, she woke up with it and it was hard to breathe with the cough (on 07Apr2021). Patient asked if she could take ibuprofen for headache and she was wondering if the cough was normal and can she take cough syrup. She stated that she needs something, she was coughing and hacking. Patient stated that every time she coughs her head was pounding. She could not eat and she was an eater. Patient said that she tried to get coffee down this morning and forget it, she was not really feeling hungry (on 07Apr2021) which was unusual for her, normally she would eat whatever you put in front of her. She didn't eat anything right now. As far as tiredness she was ok, not tired right now. Patient stated that she did feel tired (on 07Apr2021) yesterday but feels uncomfortable with headache and cough. Patient had no emergency room and physician office visit. Event severe headache, between the eyes and very bad cough, she woke up with it, it was hard to breathe with the cough was worsened. The outcome was recovered for yesterday she was tired when she got her shot, yesterday morning she slept all day (tired) on 08Apr2021, not recovered for (very bad cough, she woke up with it, it was hard to breathe with the cough, worsened), (severe headache, between the eyes, worsened) and unknown for rest of the events. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

A cough that is different than anything I have ever heard or had. Had it over a month and it hasn't gotten any better. It chokes me sometimes and one time I stopped breathing because I was choking. Energy level very low and usually I have a lot of energy and never get tired. It is hard to do a little bit of work and I used to go go go all day. Labored breathing often. Fatigue.

Two days after the vaccine I woke up achy and with a slight fever. Not long after I woke up I began having trouble thinking through sentences and had some trouble speaking. I goto up to get some water and was dizzy. I walked into the wall repeatedly. During the rest of the day I couldn't remember anything from one minute to the next. Cognitively I couldn't put things together. It was terrifying,like being in a box and not. being able to get out. This lasted for about 24 hours.

Fever - 102F starting 12 hours after vaccine and subsiding 48 hours after. Body aches - starting day after and ending after 48 hours. Vertigo (spinning) starting 10 days after shot and continuing off and on to this day. Dizziness - starting 10 days after shot and still a problem daily. Nausea - with episodes of vertigo. Feeling off balance - same time frame as dizziness Tinnitus - same time frame as dizziness - constant. Blurry vision - same time frame, 3-4 days a week. Increased eye floaters - same time frame. Brain fog - comes and goes. Motion sickness triggered by riding in a car or side motion in my field of vision. Sensitivity to sound. Sensitivity to light.

A couple of hours or so after the second vaccine my body felt achy and feverish. Also started to get the chills and then a headache. The symptoms gradually got worse over the course of time, took a couple of Advil and went to bed. It was difficult to sleep as my legs ached so badly I could not get into a comfortable position. As the night progressed and and fell in and out of sleep, the pain and especially the chills and headache were unbearable. I woke up around 10-11 pm with my throat numb, feeling tight, my tongue was numb at the back and the front area of my tongue was numb and tingling. I was nervous and scared to go back to sleep. My family all asleep and did not want to unnecessarily awaken them. I put myself into an upright position for fear of anaphylaxis. Considered calling 911= but we live in a quiet community and waited to see if it got worse. I did not sleep all night, finally got some rest while sitting upright. The following day all the symptoms were there and fever, chills and body aches worsened. My temp was around 101. Drank a lot of water. Today, my throat does not feel the same. Feels like something is there but cannot describe the feeling. Have been tired these past couple of days. Not usual for me but cannot say it is due to the vaccine. I will comment in that I never had the chills so bad as I had experience with actually being sick. Was horrible.

I am doing better now. Received the vaccine on Saturday about 2:30 pm, and felt fine until later that night when I had serious muscular pain. The following morning I felt fairly well, until about noon or 1 pm, when I had chills, low grade fever and fell into a very serious mood swing/ depression which is very unusual for me (almost suicidal depression). Monday, I had more muscular pain and had trouble with my right wrist. I continued to have serious low mood but by Tuesday morning was better (not as seriously depressed). I still have low to mid level anxiety, but I am starting a new job which might be part of that. All other symptoms are now gone, including the serious depression. I simply thought it should be noted.

I had a foggy brain. I'm forgetting stuff, I have impaired vision, dizziness, off balance. I got an MRI done Extremic disorder, fatigue, headaches. Swollen in my legs, extreme dry eye, blurred vision. I have chest pains on and off. I had to see a Neurologist. And I am still under doctors orders. I am now having allergic reactions that I have taken in the past before the vaccine. I went to an ENT doctor. I have to get a psychological test. I have to take a balance test. I have to see a Cardiologist.

Headache worsening after about 6 hours and pain at injection site. Headache continued during the night, with restlessness, muscle soreness preventing sleep. Headache continued after getting up around 7 am, with nausea. Started drinking water, vomited around 10 am. Ate 2 pretzels, drank ginger ale. Fever of 99 degrees, chills. Took tylenol. Vomited around 2 pm. Tool Emetrol. Headache worse. Vomited at 4pm. and again at 6 and 8. Went to ER at 9. Vomited 2 more times while waiting. Given meds for vomiting, pain and IV fluids around 11:30 pm.

She got the vaccine about 5:30 PM May 24, 2021, and initially did fine. In the middle of the night she awoke short of breath, coughing, felt she could not breathe. She denied any itching or hives. Denied any swelling in throat or mouth. Tried antihistamine. Next day, went to work, still short of breath, and in mid day came to see us in the office. She was wheezing and oxygen saturation was 89%. ( 96% is normal), and hypertensive. RR was 24-30. BP was 160/104. We sent her to ER for possible anaphylaxis to covid vaccine. In ER was treated with albuterol nebs, duonebs, prednisone, and admitted to the hospital on 8 liters oxygen. She was in hospital 5/25/21 to 5/27/21 and sent home off oxygen, on prednisone DC diagnoses were Acute respiratory failure with hypoxia Systemic Inflammatory Response Syndrome Tobacco Use elevated BP reading Chest pain Anxiety, COPD exacerbation (I would comment she has never had this before; hospitalist made that diagnosis based on cigarette use and wheezing and hypoxia)

01/08/2021 - The shot did hurt. The next morning, I felt bad, I went to work and they scanned my temp, I felt fatigued and feverish. I took the next few days off work.

Numbness; tingling; moderate to severe pain in right hand; It wakes me up at night, it's so bad; Visual disturbances (floaters in left eye constantly).; This is a spontaneous report from a contactable Nurse (reporting for herself). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown) 2nd dose, via an unspecified route of administration administered in Arm Right 23May2021 at 12:00 pm, as single dose for covid-19 immunization (at the age of 63-years-old). The patient medical history was not reported. The patient was not patient diagnosed with COVID-19 prior to vaccination and since vaccination has not been tested positive for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA); trazodone (TRAZODONE) and hydrocodone bitartrate, paracetamol (NORCO) all were taken for an unspecified indication and start and stop date were not reported. patient previously experienced allergy while taking codeine, Ativan and augmentin bambini. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), via an unspecified route of administration on 2May2021 at 12:00 pm, as single dose for covid-19 immunization. Caller stated that after receiving second dose of vaccine on 26May2021 08:00 am the patient experienced numbness, tingling, and moderate to severe pain in right hand. it wakes me up at night, it was so bad. visual disturbances (floaters in left eye constantly). Patient visited to the emergency room/department or urgent care for the events. The outcome of the events was not recovered. Information lot/batch number is requested.

I got the vaccine at 9am. At 4pm that same day I experienced terrible pain to left arm. No redness or swelling at the site. I couldnt lie on my left arm at all that night. By 11pm I also experienced headache, sinus drainage, sore throat, body aches, taste and smell were off, upset stomach, queezy stomach but no nausea or vomiting, very weak , dry mouth, fever at 99.2 then 98.6, chills, lots of chills. The covid hotline at my work told me I had a moderate reaction to the vaccine. Treatment was rest and tylenol which didn't alleviate any symptoms whatsoever. I had all these symptoms til Jan 6th at 4am. At 4am all the symptoms left and have not returned.

Five minutes after receiving the Pfizer Covid-19 vaccine, the pt. informed the RN that she was feeling "itchy" on her right arm, her right scapula and across her abdomen. She was given the vaccine in her left arm. The pt did not have any rash or hives noted. The PA spoke with the pt and 50 mgs Benadryl was given p.o.(@ 1450). The pt stayed to be observed and after an additional 40 minutes (@ 1531) she said she was feeling better and was going to her unit to work (eve shift). The pt. spoke to her Nurse Manager upon arrival back to her unit and was sent home instead of working. Her unit was called at 4pm and we were informed that the pt went home, as she was concerned of being too tired to work.

Fatigue Narrative: Went to work for a few minutes -- really tired. Fellow employee said she should go home or be reported. First shot had a sore arm & a bit of a cold for a few hours and back to work. This time has sore arm and is more tired than usual. 98.7 F No cough, HA, N/V. No medications taken for s/e.

Dizziness, HYPERtension & Tachycardia Narrative: 5 min after vaccine administered L arm felt dizzy. 170/100, HR 133, 97% RA at 1220. Reported poor sleep and mild anxiety. 115/76, HR 116, 96% RA at 1234. At 1237 denies any dizziness or other adverse effects.

Difficulty swallowing, fever 102, headache, ears plugged, earaches, all joints ache including fingers, ankles, etc., legs ache, shinbones ache, roots of teeth ache, chills, nauseous, dizzy, delirious, ovaries ache, short of breath, brain fog, not able to multitask, vomiting, sore throat, cough, left arm pain

Customer rec'd COVID-19 vaccine at 0907 in facility and transferred to post vaccine observation. At 0917 customer called out to provider. Customer reports "a funny feeling" and states that she has commonly felt this feeling prior to allergic reactions. She appears anxious. Customer moved to ante room, closer to emergency supplies. Customer denies feeling SOB, difficulty breathing or tongue/throat swelling. Reports "heart racing." BP 205/100, HR 121, 02 98%. Lungs CTA. Customer accepts Benadryl 50mg PO @ 0920. Customer monitored at site. Over the course of the next 5 minutes she reports feeling better and more relaxed. HR decreases to 78, BP 190/78 @ 0930. Customer reports full resolution of symptoms. Reports having this type of reaction before to oral medications and has previously been monitored in the ED. She denies ever having to receive EPI, and is unsure what treatments were given in ED to resolve symptoms. She has never been admitted for one of these types of reactions, and reports this reaction as a mild compared to others. Customer's husband called to bedside. Customer and escort counseled to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED. Customer and escort in agreement with plan. Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer denies questions/concerns. Escort verbalizes understanding of instruction and agrees to remain with customer for the next 24 hours. Customer released from site at 1005, ambulating independently with steady gait, no obvious s/sx of distress.

Vaccine was administered on 12/30 at around noon. I felt fine that day but was aware that a previously diagnosed but inactive area of contact dermatitis on my right knee was flaring up - becoming very pruritic and active. Over about 48 hours it became red, blistered and eventually weepy. The area had been biopsied in September of 2020 ("spongiatic dermatitis"), treated with topical steroids and for the most part resolved. I saw my dermatologist on 1/6 - repeat biopsy was done ("severe allergic reaction") and it was treated again with topical steroids and is resolving. On 1/12 I began experiencing generalized pruritus. I have patchy erythema, dermatographism, and a few scattered solitary urticarial lesions. There are no respiratory symptoms - specifically no shortness of breath, cough, bronchospasm, swelling of mouth, lips or tongue. No joint pain. No fever. I took zyrtec 10 mg with minimal improvement. I contacted my dermatologist today who feels this is an Id reaction and suggested reporting the reaction to VAERS. I have also contacted my primary physician and have a telehealth visit scheduled. The biggest question is whether to have the second dose of the vaccine, as I am a physician actively seeing sick outpatients.

Immediately felt "strange" after receiving the vaccination. Developed hypertension, muscle aches, extremity swelling.

Patient reports flu like symptoms, felt very cold and myalgia. Next day she self treated and went to work and had to leave. Patient reports night sweats, severe fatigue. Patient says the night sweats is the reason she is calling.

awakened at 3am with fever 101 and shaking chills the night after my second SARS Pfizer vaccine. flu-like sx lasted for one day; fever resolved by this am 1/13

Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Systemic: Abdominal Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Nausea-Severe, Systemic: Swollen Hands. Couldn't make fist-Severe; symptoms lasted 4 days.

Vaccine recipient received vaccine on 1/10/2021 and reported severe fatigue. She woke in the middle of night with severe bilateral leg pain, similar to sciatica, painful to get out of bed and walk, similar to Charlie Horse. She took Tylenol and laid around most of the day 1/11/21. Pain in right leg stopped in evening on 1/11/21, however pain continues in left leg. Nerve pain in left leg is still continuing from left gluteal muscle to inner thigh above knee cap. She declined occupational health follow-up and will self-manage at home. Pfizer-BioNTech COVID- 19 Vaccine

Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Systemic: Abdominal Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Nausea-Severe, Systemic: Swollen Hands. Couldn't make fist-Severe; symptoms lasted 4 days

Employee reported having SOB with chest pains, severe headache (rated pain as 8/10), excessive salivation with nausea, lightheadedness, she has a h/o migraines headaches and was incapacitated for 24 hours, Employee she was treated and sent home by end of her scheduled shift

I experienced excruciating pain in my middle back--it woke me from my sleep. It felt like that entire area was in pain. I could not been over without twinges of spasms. I could walk without problems--including up and downstairs (with extreme caution). On 1/16/21 I started taking Bayer for Body and Back pain and using Icy Hot on the area that hurt. I called my doctor's office for med for spasms and she said I need to see a doctor. I wanted to be compliant with her recommendations. The doctor suggested Extra Strength Tylenol every three hours.

After I received the vaccine went home rested temp went up one time 99.0. The next day woke up heart was pounding check my BP 150/80 laid back down. I woke up around 5pm my BP had elevated to 160 (don't remember diastolic reading) pulse rate normal limits. I informed my spouse of what was happening called 911. At the hospital checked vitals, EKG, CT Scan, Chest X-ray, Blood work and Potassium was low took 2 Potassium pills. I went back home on 12/31 returned to work did fine that day. On New Years day everything started back again discomfort went back to ER. I felt like force in my chest the doctor collected my information and I was placed on a low dose BP medication until I return to my PCP, cardiologist(stress test). I followed up with PCP via Telehealth about my BP concerns, my dosage was increased to 25 mg and due to my symptoms I was placed on leave from work 2 wks. I also have a appointment scheduled with Neurologist.

Fever 101.5, migraine, eyepain, severe arthralgias, nausea and vomiting, weakness, inability tji think clearly. Residual symptoms at the time of this report

bloodshot left eye; injection site soreness/injection site soreness of L arm; Lack of energy; (time) confusion; lightheadedness; headache/slight headache; This is a spontaneous report from a contactable nurse, reporting for herself. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection lot number: EL1284), intramuscularly on the left arm on 05Jan2021 18:30 at a single dose for COVID-19 immunization. Medical history included received immunotherapy injections for environmental allergies from an unknown date and unknown if ongoing. Concomitant medication included diltiazem, spironolactone, trazodone, lorazepam, colecalciferol (VITAMIN D), zinc and fish oil. On 05Jan2021, the patient received Pfizer COVID-19 vaccine and experienced (time) confusion, and lightheadedness within one hour of receiving. Later that evening, the patient experienced headache. On 06Jan2021, the patient experienced injection site soreness x 2 days, continued with slight headache, lack of energy. On 08Jan2021, resolved injection site soreness of left arm, continue with slight headache. On 11Jan2021, The patient woke up with bloodshot left eye after having had headaches x 5 days which began the same evening of receiving the Pfizer COVID-19 vaccine. Blood pressure was 125/80. No headache or eye pain. BP was 128/89 on 10Jan2021, 11 PM. No headache. BP was 120/80 on 11Jan2021, 10 AM. The patient had never had a bloodshot eye before. The patient underwent lab tests and procedures which included Blood pressure:125/80 mmHg on an unspecified date, 128/89 mmHg on 10Jan2021 and 120/80 mmHg on 11Jan2021. The outcome of the event injection site soreness/injection site soreness of L arm was recovered on 08Jan2021 while the outcome of all other events was unknown.

forceful beat feeling in her chest/she was really uncomfortable in her chest, the force was the most uncomfortable at this point; seemed like UTI symptoms were coming back; felt really wiped out and worn down/tired; anxiety; racing/ pounding in chest; potassium was a little low; elevated blood pressure; arm a little bit sore; 99.1 degrees Fahrenheit fever; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via intramuscular on 28Dec2020 07:15 at single dose on deltoid left for COVID-19 immunisation. Medical history included hepatitis C which cleared in 2016, hysterectomy was done in 2004 or 2005, cyst removed from breast long ago, ongoing arthritis in left knee, urinary tract infection was treated in Nov2020. The patient's concomitant medications were not reported. She received the first vaccine on 28Dec2020. She did fine that day. She came home and laid down and rested. Her temperature went up to 99.1 degrees Fahrenheit but was resolved that same day/night. Early in the morning on 29Dec2020, around 3:30 a.m., she woke up and had a racing/pounding feeling in her chest. She took her blood pressure and it was 158/86, heart rate (HR) was 83. She felt really funny. She hadn't been diagnosed with high blood pressure before, so this was high for her. She took her blood pressure again about an hour later and it was 165/95, HR 73. She took it again about an hour later and her blood pressure read 180/98, HR 77. Her heart rate stayed in the normal range, but the force felt really strong. She did go to the emergency room around 5:00 am on 29Dec2020. She told them what she was experiencing and that she had received the COVID-19 vaccine. About the time she got to the hospital, her blood pressure was starting to come down. An EKG was done and they drew bloodwork. Her potassium came back a little low-they didn't tell her how low or what her level was. She was given 2 potassium tablets which did help. She confirms she doesn't have any NDC, Lot number or expiration date for the potassium she was given. It was given to her at the hospital. She was also given a sheet to monitor her salt intake, which she already does that. She confirmed she was not admitted into the hospital, she was discharged from the Emergency Room. She felt pretty good. She didn't go to work that Wednesday, 30Dec2020, but she went to work on Thursday, 31Dec2020. On 01Jan2021, the same thing happened to her again. She had elevated blood pressure, forceful beat. She went back to the ER early in the morning, around 5:00 am, on 01Jan2021. Her pulse stayed within normal range, but she had such a forceful beat. She informed them that she was really uncomfortable in her chest, the force was the most uncomfortable at this point. They wanted to make sure she wasn't have a stroke or heart attack, so they did their normal procedures to rule this out. They did 2 EKG's, 2 sets of labs, Chest X-ray, CAT scan and everything came back normal. She had a discussion with the physician that saw her about what she was experiencing and the physician was asking her about having anxiety. Caller explains she has never really had problems with anxiety before, but she can't say she hasn't had it. Being around COVID patients and getting the shot, sometimes anxiety can be there. The physician wanted her to try a low dose of Hydrochlorothiazide 12.5mg. She was to only to take a half dose by mouth, if her top number (systolic blood pressure) was between 140-160. Caller clarifies when she means half of a dose, the dose equals 12.5mg. She was instructed to take this 12.5mg dose until she saw her PCP. So, she did this and called her PCP and wasn't able to get an appointment to speak with a provider until the following Wednesday, 06Jan2021. She did a tele visit with her provider and let her know what had happened and that the half of the pill will only bring her top number (systolic blood pressure) to 130's-140's. Caller states she was used to her top number (systolic) being maybe in the 120's, low 130's. Her doctor increased her dose to 25mg. She was prescribed to take 25mg, tablet, by mouth, once a day. She confirmed she still checks her blood pressure before she takes the medicine. Caller verifies she has 2 bottles, one being the 12.5mg dose and the second being the 25mg dose. With the 12.5mg bottle, she sees refills and the date 05Jan2022. Caller clarifies both bottles are dispensed in pharmacy vials with no NDC, Lot number or expiry date. About a month prior to all of this and receiving the COVID-19 vaccine, clarified as Nov2020, she was treated for a UTI. During that time, her blood pressure went up a little and kind of bounced around a little bit, but came back down. Then, she got the COVID-19 shot. She initially felt fine but later on by the time she got a chance to do the tele visit with her PCP, she was telling her about her previous UTI, and the provider put her on Cipro because it seemed like her UTI symptoms were coming back. Caller verifies she doesn't have any NDC, Lot number or expiration for the Cipro. She already took of all of that. She went to the ER for the third time on 08Jan2021 because she again felt the forceful beat feeling in her chest. She explained she felt really wiped out and worn down and she was tired. An EKG was done and they did labs. She confirms she doesn't have any results with her at this time. She was taken off of work for a couple of weeks. She is currently getting in contact with a Cardiologist to make sure everything is alright. The cardiologist wants her to have a stress test. The caller states so this is where she is now. She is taking blood pressure medicine and getting set up to do a stress test. Sore arm outcome: Caller confirms she recovered from the arm soreness within that same day. Her arm didn't stay sore long at all. Racing/pounding in chest: This had improved. It's not like it was. She still has it a little bit of it now, but she is going to see her cardiologist and do a stress test. The blood pressure medicine has helped some. Elevated blood pressure: Today her blood pressure top number got to 161 and she had to take medication but her blood pressure has improved. Outcome of elevated blood pressure, racing/ pounding in chest was resolving; outcome of forceful beat feeling in her chest, UTI, potassium was a little low, felt really wiped out and worn down/tired, anxiety was unknown; outcome of arm a little bit sore, 99.1 degrees Fahrenheit fever was resolved on 28Dec2020.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

patient developed a fever right after injection, went up to 103.5 overnight, called off work the following day sick - headache and vomiting

Patient experienced tachycardia/anxious during 15 minute monitoring period after receiving first dose of Pfizer lot# EK9231. Patient was kept for an additional 15 minutes and improved within 10 minutes of the dose. Patient received vaccine on 1/15/2021.

HR 80, 98 SPO2 on RA, 170/98 , 2 160/92, 99 % RA HR 98, 99 % HR 88, 160/90 Pt states she feels dizzy, denies pain at the site. Says she does have DMII and HTN. Ambulated to restroom with RN, given bottle of water, states she has not eaten all day, states she feels anxious and vision is blurry. Pt denies headache, weakness, pain, nausea. Patient verbalized understanding to f/u with 911 or ED with any further problems. Pt also signed hardcopy.

Patient was at end of 30 minute monitoring and stated she "felt off, my throat feels dry." Able to sip water. Continuously monitored for additional 10 minutes when she stated her throat felt tight. BP 150/85, HR 97, RR 20, p. ox 99%. Sent to critical bed in emergency. Epinephrine, Solu-medrol, and normal saline given. Monitored until 11:18 (3.5 hours from onset) and discharged.

Patient was found with AMS 1 day after receiving vaccine. Patient had pain at the injection site and fever of 103.

Approximately 18 hours after the injection, I felt like I had been hit by a truck. My arm hurt like blue blazes, itched intensely, and I had a fever of 102.4. To get my temperature down to 100 degrees I had to alternate Motrin and Advil. I continued to have a fever, headache, body aches, chills, and lethargy for the next 48 hours and stayed in bed because I felt so awful. Unable to do normal activities of daily living.

Normal sinus rhythm but throwing PVCs; Elevated pulse with chest tightness; Elevated pulse with chest tightness; A little atelectasis in lower left lung; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the first dose of bnt162b2 (lot number: EL3248), via an unspecified route of administration in left deltoid on 14Jan2021 09:00 at single dose for covid-19 immunization. Medical history included ongoing does not have a thyroid; allergies/intolerance to gluten and dairy, allergies to molds, dust and some seasonal allergies; all ongoing. Concomitant medication included levothyroxine from Feb2013 to unspecified date, from unspecified date and ongoing for "does not have a thyroid". The patient previously took codeine and experienced allergic reaction occurred at 13 years of age with unknown cough syrup with codeine, levaquin and experienced allergic reaction occurred probably while she was in her 20s (age in years). She had fallen asleep on the couch about 9:00 pm on 14Jan2021. She woke up about 9:30 pm on 14Jan2021 and had an elevated pulse with chest tightness. She had to go to the emergency room in response to elevated pulse with chest tightness. In the emergency room they were not able to do anything other than hydrate her and all of that but it took about 12-13 more hours for her elevated pulse to come down (15Jan2021). Her biggest question was that she saw where some reactions are fast heart beat but she was kind of surprised at how long after the dose was administered that she had onset of the elevated pulse. She saw Cardiologist 18Jan2021 related to this event and the Cardiologist was a little baffled by the event. She reported event as improved, although she still has a little bit of tightness in her chest which goes in a little bit of phases. The Cardiologist told her to still take the second dose as scheduled of the Pfizer COVID-19 Vaccine. She did not see her family doctor, she saw the Cardiologist only as referred after emergency room visit. She was not admitted to the hospital; she was treated and kept under observation in the emergency room for about 5.5 hours. She has a stress test scheduled for next week. She is planning to still get the second dose as scheduled of Pfizer COVID-19 Vaccine but she is a little scared to get it due to this adverse event. She thought the events were related with the vaccine, she had no problem prior to getting the vaccine. On 14Jan2021, pulse was 146 beats per minute which she checked with a pulse oximeter machine she has at home so she knows it is accurate; Chest x-ray: She reported that result of a little atelectasis in lower left lung was a little weird. On 18Jan2021, the EKG result was Normal sinus rhythm but throwing PVCs. She reported she knows her thyroid lab is normal because it was checked in the emergency room during visit starting 14Jan2021. The outcome of the events elevated pulse with chest tightness was recovering, other events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Sore arm immediately after getting second dose of COVID Vaccine; Chills; Myalgia; severe headache; Nausea; She felt like she had a temperature and by the time it was checked her temperature was 101.9/febrile; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at left upper arm on 07Jan2021 14:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, not a Military Facility. The patient's medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient got the Flu Vaccine last part of Sep2020 or Beginning of Oct2020. The patient received the first dose of BNT162B2 (lot number: EK57530), via an unspecified route of administration at left Upper arm on 17Dec2020 9:10AM for covid-19 immunization. She only had a sore arm. It started the same day, a couple of hours after getting the vaccine. It went away a day to a day and a half after it started. After that she was fine. She got the second dose on 07Jan2021. After the second dose, immediately, like within five minutes her arm became very sore, this event was assessed as non-serious by HCP. Also, that Thursday (07Jan2021) night after getting the second dose of the Vaccine around 9PM-10PM she started to get chills, myalgia, severe headache, and nausea. She also mentioned she was so sick during the night she was not able to get up and around. She felt like she had a temperature and by the time it was checked her temperature was 101.9. She was febrile all through 08Jan2021. She started to become afebrile 09Jan2021 with improvement and by 10Jan2021 all her symptoms had gone away and completely resolved. Seriousness Criteria: Stated she felt these are serious. She was unable to go to work on Friday. She could not return back to work until Monday. The HCP assessed all events were related to the vaccine. The outcome of the events was recovered on 10Jan2021. She stated, even though she got so sick with getting the vaccine she was just continuously telling her self this is better than having COVID. She stated she even told people even if she knew after getting the shot she would have this reaction she would still take it. She has seen death occur from COVID and does not want that to happen.; Sender's Comments: Based on plausible temporal relationship, clinical course and known safety profile of the product, the reported events chills, myalgia, severe headache, nausea and fever were likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

My arthritis pain is gone; vivid dreams; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), via an unspecified route of administration on 12Jan2021 09:00 at a single dose for covid-19 immunization. The patient's medical history included allergy to IVP DYE, and osteoporosis from an unknown date. Concomitant medication included alendronate sodium (ALENDRONATE). The patient previously took varicella zoster vaccine (shingles vaccine on 03Dec2020), and povidone in generic tablets and experienced allergy. On 15Jan2021, the patient experienced her arthritis pain was gone. The patient also mentioned that she had vivid dreams in Jan2021 and haven't dreamed in years. The outcome of the event swas unknown. The patient did not received treatment for the event. The patient diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.

Sore Injection site left arm (same arm as first one) thru the armpit, swelling in left arm, tiredness & fatigue, foggy brained, extreme body aches and pain, unable to walk from weakness, nausea, excruciating headaches, irregualar heartbeat, nausea. Reddness and swelling in arm for over 1wk. Nausea about 10 days.

Arm started hurting about 6 hours later. That night she was restless. Temp was 100.7, Took Advil, temp came down. The next day, she experienced chills, joint pain, body ache. The next day, still had symptoms but not as bad. She is getting back to normal but is still having some mild symptoms.

Immediately following injection the patient developed paresthesia's of the lips. Six days later he developed symmetrical paresthesia's of the lower extremities that have progressed up the legs to the knees bilaterally. Additional symptoms include brain fog, fatigue and migraines with increasing frequency. Symptoms have continued to progress now one month later. No treatment. Pending neurology evaluation.

Severe rash began on 1/25 , about 11 days after second dose of vaccine. Rash was erythematous, was not raised. Began on chest then spread all over body. Extreme pruritis, relieved for only 2 hrs after doses of 50 mg Benadryl each time. Took Prednisone 20 mg on 1/27 then 40 mg on 1/28 with no relief. On 1/29 went to ER because of exhaustion due to not sleeping secondary to pruritis. In ER was treated with IV Decadron, IV Pepcid and IV Benadryl. CBC and BMP were normal. Dermatologist was contacted by ER via phone . Felt reaction was due to the vaccine and to report it . I was prescribed Claritin 10 mg QID and Pepcid 40 mg daily. Rash resolved after 48 hrs. No SOB.

Anaphylaxis; SOB (shortness of breath)/ difficulty breathing; Chest tightness; dizziness; Wheezing; Anxiety attack; Medication-induced allergic reaction; Blood pressure (BP) increased for 130/89; This is a spontaneous report received from a contactable pharmacist. A 64-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), intramuscular on left arm on 16Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), mopericarditis, anxiety and allergy to antihistamine tabs. The patient's concomitant medications were not reported. It was reported that, the patient was experiencing chest tightness, SOB (shortness of breath), and dizziness on 16Jan2021. 50 mg of Benadryl and 20 mg of famotidine was administered around 14:10. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3 mg of epinephrine was administered at 14:20. EMS was called. Breathing improved. Pulse Ox 100%, HR (heart rate): 68, blood pressure (BP) increased for 130/89. EMS arrived and assumed patient care. ED COURSE: Patient was seen and examined with doctor. Patient developed of SOB, dizziness, wheezing after receiving first shot of Pfizer COVID vaccine. She received Benadryl upon development of symptoms, which actually made them worse given her allergy to antihistamine tabs, but her symptoms improved upon administration of 0.3 IM epinephrine shot. Differential diagnoses include but were not limited to anaphylaxis, anxiety attack, medication-induced allergic reaction on 16Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. The patient visited emergency room/ department or urgent care due to the events. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19, since the vaccination. The events were assessed as non-serious by the reporter. Therapeutic measures were taken as a result of events. The outcome of the events was reported as recovered on an unspecified date in Jan2021.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The treatment with Benadryl most likely contributed to the events as the patient is known allergic to antihistamine tabs. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

During the first 10 minutes of shot, while in the store, I got a mild chest pressure. Did not think anything of it at first. Thought might have been heartburn or nerve. However, it persisted along with periods of mild and sometimes a bit more moderate chest pain for about the next 8 hours but never got sever. Around 11:30 p.m., I decided to lay down and if not gone in a couple of hours, I would go to E.R. I feel asleep and when I woke around 2:00 a.m., the discomfort was gone. The next day I looked on internet because flyer given did not say anything about chest pressure and pain, just difficulty breathing, but I found a site that listed "persistent chest pain and pressure" as an adverse reaction. I am now wondering if this was considered an adverse reaction and if I need to be concerned for the next dosage. I have left a message for my physician, and plan to call pharmacy today. I want to get the next dose for protection but now I am nervous. Can you advise? I have listed my cell number, or please contact via email. I am so confused as to what to do. Thank you.

fast heartbeat, dizziness and weakness, excessive fatigue/tiredness, chills, joint and muscle pain, back of the neck/headaches and pain, disoriented, injection site swelling, tenderness, and hot to the touch, fever, sinus infection like symptoms ( stuffiness, difficulty breathing, ear pain, sinus/facial pain )

I woke up 37 hours after first dose of vaccine with dizziness, which became dizziness. I began vomiting within a couple hours. Around noontime I vomited twice more. I got worse, could not walk around. I felt extremely sick but felt better when I lay down in bed. I was not able to go to work, had to cancel the substitute teaching assignment I had taken. I did sleep some. No doctor called me back except my daughter texted with me. She is an intern, said she wished she could be with me. My neighbor brought some Pedialyte. This morning, the next day, I am still weak and nauseous, but it is less. At the end of the day yesterday, I did eat a little rice with carrots. And I just ate a little plain oatmeal with raisins and salt. I am praying the 2nd dose will not be worse, as my daughter warned, because I can't remember when I was so sick and incapacitated. Maybe a long time ago.

When trying to drive to work the next day, I experienced extreme light sensitivity. While I am light-sensitive in the morning when the sun is low on the horizon, especially when there is snow on the ground, as was the case that morning, this was far more extreme than usual. I was wearing a very good pair of sunglasses I bought at an eye-doctor's office that protected from both the front and the sides. Still, I felt as though I had a strobe light flashing directly into my eyes. I was driving through town, in very familiar area, I realized when I got out of town into less familiar area, it would be unsafe to drive. I went back home and called work and told them I was not well enough to go to work that day. I later called the nurse who gave the vaccine and explained the situation to her. I received no treatment. I had my eyes examined the next morning and was told to use eye-drops four times daily for at least two months.

I had my 2nd dose of covid vaccine on 1/15, around 5 pm. Next day when I got up about 7:20 I felt dizzy nausea and wanted to vomit. Then I passed out, I fell down and hit my face on the floor. My family called 911 paramedica. They ,measured d my blood pressure and it was too low. The area around my right eyebrow was swollen and my neck hurt as precaution I went to the hospital. I suspect the incident and its symptom are side effects of the vaccine given the timing. Later on I had headache off and on and brain fog.

With in seconds of receiving vaccine had seizure like effect in head resulting in out of body like experience, muffled hearing, a foul taste in my mouth and altered state of eurphoria. Could not report symptoms but if had been asked directly could have. REalised half way driving home that I should not be driving. Eurphoria lasted for 24 hours. Was on phone constantly the next day for 7 hours straight without eating. Could not remember what some items were like a drone. Had to ask = that thing that flies with a camera. Short term memory loss that continues. Facial numbness began 48 hours after injection. Facial numbness continues changing in areas of right side of my face. Felt extremely vulnerable. Wore my same clothing for 4 days as I did not remember that I had clean clothing. Did not remember that I should notify medical personal until late 2/20.

Sweating, nausea, dizziness, aching joints. Effects seem to come in waves, sometimes feeling ok, and then completely down for a couple of hours, ending by day 3. Have been constipated for five days now, with no bowel movement since vaccine. I have had extreme insomnia since vaccine.

Moderate to severe pain in arm, shoulder, back started about one hour after shot. Lasted until next morning. No medication taken. Moderate headache lasting through next morning, general grumpiness for 2 days, brain fog beginning following morning - forgetfulness, depression. Still continued through today (Monday, March 1, 2021). Symptoms are not severe, but are acute enough that they are impacting quality of life.

About four hours after the innoculation, I began to get nauseous. Three hours after that, I had vomiting and diarreah that lasted most of the night. I had chills, aches and headache which tylenol helped relieve. I began to feel better 24 hours later but still experienced extreme fatigue. It is now Tuesday (vaccine on Sunday) and I am still fatigued and have trouble concentrating.

Severe difficulty breathing; difficulty breathing frightened her; This is a spontaneous report from a contactable consumer (patient). A 64 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9262), intramuscular (on the upper left shoulder) on 27Jan2021 09:20 (at the age of 64-year-old), single dose for COVID-19 immunization. Medical history included ongoing hypothyroidism diagnosed about 14 years ago, breast cancer from Dec2017 and ongoing diagnosed in Dec2017, ongoing asthma she was diagnosed with asthma when she was 39 years old, surgery from an unknown date, she had surgery to correct a deviated septum and her asthma got better, she has high blood pressure after all the treatment. Concomitant medication included salbutamol (ALBUTEROL). On 27Jan2021 she had the first injection. It was about 14 to 16 hours after the injection that she had severe difficulty breathing. Reported she has asthma. She was a cancer survivor, and she has high blood pressure after all the treatment. The difficulty breathing woke her out of her sleep. She had to call the doctor since she is concerned about her second dose which is scheduled for 17Feb2021. The difficulty breathing frightened her, and it was not an immediate reaction, she had the shot at 9:30 am (clarifies she received the injection at 09:20 am) and between 1 to 2 am in the night, she woke up not able to breathe. She could not use her inhaler since she could not really breathe in. She was obviously able to get some air in since she did not pass out. She contacted her doctor and he will send her a prescription to get an Epipen, so she has it on hand when she gets her second dose. Her doctor does not want her to not get the second dose. States she is concerned about other asthmatics receiving the vaccine and wanted to call and report this. She expected it to happen onsite where she received the injection but it did not. Her doctor asked her if she thought it was an asthma attack and she told her doctor that she has not felt like this in 24 years. Treatment/Outcome: She stepped out into the cold to shrink her airways and then was able to use her inhaler. Reports it was not a 2 hour episode thank god, and within 15 minutes she was able to force an inhaler dose in. Everything is fine. She is a breast cancer survivor and cannot use her right side so she had the injection on her left side in her upper shoulder, she has to wait 5 years to be considered cancer free. Her doctor suggested to use her albuterol inhaler for 4 days in advance of getting the second dose of the vaccine. She would think that would be abusing her albuterol but she will do that since she was instructed to do so by her doctor. She was terrified. She will have an Epipen on hand when she goes to get her second dose. She understands the symptoms can be worse with the second dose, she is anticipating everything should be fine. The outcome of the event difficulty of breathing was recovered on Jan2021, for the other event was unknown. No additional vaccines administered on same date of the Pfizer Suspect. No AE(s) following prior vaccinations, states she has had everything. No Prior Vaccinations within 4 weeks.

very active stomach, diarrhea due to problem (nervous)/bowel movement really often; very active stomach, diarrhea due to problem (nervous)/bowel movement really often; Stool being dark is concerning; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EL8982), intramuscular in right arm on 29Jan2021 at SINGLE DOSE for Covid-19 immunisation. Medical history included high blood pressure and had insulin resistance. She had her first dose of BNT162B2 on 03Jan2021. Concomitant medication included metformin. She also mentioned 'Candistan Clotrimazole' (not clear nor clarified) something like that, and also took 'Premarin' (not clear nor clarified) it's hormone for menopause. She got the vaccine instead of 21 days it was 26 days. Since when she had the vaccine, her stomach was really active, diarrhea due to problem (nervous). She informed having bowel movements like really often. Today (Jan2021), she already went twice but the thing was she was going and it was like too dark, mentioned that stool being dark was concerning. She took Libertrim S11 Trimebutine Simethicone, for diarrhea. The outcome of events was unknown.

Approximately 7 hours after immunization, I experienced a change in orientation. I did not remember getting a vaccination, day of week, month, color of my car, president. However, I knew my name, birthdate, people who were with me at the time of the event. I experienced no speech or mobility impairment. I was able to walk with no difficulty in my gate. My grasp was strong and equal. No facial muscle weakness was noted. 45 minutes later I had total recall of the day's activities. I am not a smoker, no consumption of alcohol or illegal drugs. Called primary care physician on 3/5/21 at approximately 4:30 pm. Primary physician was not available, spoke to a nurse.

As the needle was being inserted and while the vaccine was being injected, I immediately felt intense pain like none I've had during any prior vaccine administration . The needle was inserted very high on the arm about 1/2 inch below the shoulder. About 4:00 pm that afternoon, new pain developed in the same shoulder, along with very limited range of motion, gradually worsening during next few hours. By 9:00pm the pain was excruciating, like there were multiple knives in all directions in my shoulder. By then I could not lift or move my arm any amount in any direction without excruciating pain. I suspected a severe inflammatory response. This pain level continued for the next 2 days. On the 3rd day the pain was a little less severe and I had slightly more range of motion, but was still unable to lift my arm without pain. On the 4th day (Feb. 18) the pain was a little better but I still had severe sharp pain if I lifted my arm in certain directions. I began to suspect a torn muscle or tendon. Today (March 5, almost 3 weeks after the vaccine), the pain and limited range of motion are the same as Feb. 18. It is relieved only by complete rest of the arm, and easily aggravated by any basic activity (grocery shopping, dressing, etc.) I believe my shoulder was injured by improper administration.

Approximately 17 hours after vaccine, suddenly got very tired, brain fog, and had some type of sleep attacks, yet couldnt sleep, head just nodded up and down. felt very hot suddenly from the sides of the throat down straight and under both breast, felt as if I was being squeezed to death. chest felt very heavy. yet not gasping , or breathing fast. Im a respiratory therapist disabled now. I took bp was 120/80, o2 sat was 97, heart rate was 16, pulse 83. I could not lie down as felt as if being smothered. had to lie down but elevated very high. felt as if throat and chest were hot, but i did not get up to see if red, as i was having severe brain fog and oh so sleepy, yet felt so wired on friday evening March 5,2021 when I had the shot. I was awake, this tiredness and heaviness didnt happen until 1pm the next day. Saturday evening, I took o.1 ativan , thinking it was maybe anxiety as the brain for cleared after 3 hours, the chest heaviness got better, but still persisted over to sunday, march 7, but throat feeling closed in dissipated after 3 hours on saturday. 3/6. Sunday still unable to lie down as chest still felt heavy, bp 140/80 which was elevated. pulse elevated, respirations were 20. however all side effects seemed to be subsiding

Extreme anxiety. I felt like I was coming out of my skin. Extremely anxious. I had to walk outside several times. Felt very fatigued. Not nervous but as if I couldn?t stay in one place.

I was okay until after arriving home at which time I developed and headache and exhaustion. I went straight to bed for 2 days with headache, stomach pain, couldn't eat or drink. I started to feel a little better but still was unable to eat and was fatigued. When I did try to eat I got terrible diarrhea almost immediately. Over the next few days, realizing this was probably not normal, I contacted the advice nurse at my provider and eventually talk to a doctor on Friday (March 5). That doctor thought it sounded like I contracted COVID. I had a test that day that came back the next day negative. I have an appointment to talk to my regular doctor on Wednesday (March 10), particularly to get advise about whether to get the 2nd dose on March 20. My blood pressure has been unusually low (as low as 85/58) but is now about 120/60. I did not have a fever. My breathing has been more labored than usual, but my oxygen level is at 97% and my pulse is around 65.

My arm hurt so badly that I couldn't lift it or sleep tiredness headache chills joint pain feeling unwell difficulty breathing a fast heartbeat weakness

One and a half hours after the vaccine, I suddenly became very dizzy and had a hard time focusing. I was extremely happy that I was NOT driving. I could not think straight and had sweat pouring down my face. My head was very heavy and as the day progressed, my neck also became sore. I took Advil and later Tylenol and they helped the head ache but not the dizziness. I lost appetite. I consulted the reading material about the vaccine and all of my symptoms were normal side effects, so I did not seek medical assistance. My daughter is a doctor and wanted me to report for statistical reasons.

Hallucinations; Anxiety; Paranoia; She was nervous; she wasn't feeling right; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration, first dose on 25Jan2021, then second dose on 13Feb2021 both at single dose on the left arm, for COVID-19 immunisation. Medical history included diabetes mellitus and hypertension, both from an unknown date. Concomitant medication includes taking an unspecified medication for years, pain pills or whatever and the doctor said that it can take up to 7 days to leave the system. On 27Jan2021 at 10:00 am, 2 days after the first dose, it was reported that patient began to have hallucinations, anxiety, and paranoia. On an unspecified date in Jan2021 after the first dose, the patient reported that she was nervous, she is not feeling the same. The events continued after the second dose. She went to the Emergency room on Valentine's day 14Feb2021, she was not admitted and went home the same day. They just told her don't drive and talk to her primary Care Doctor. She then made an appoint for the primary care doctor on 17Feb2021. She has no other vaccines on the same day or in the 4 weeks prior. She has no other family medical history to provide. The outcome of the events hallucinations, anxiety, and paranoia is slowly going down and recovering while for the rest of the events was unknown. Information on lot number/batch number has been requested.

The day after vaccine during the night I started coughing and feeling congested. Low grade fever and bas cough. Goopy eyes similar to pink eye and congestion and coughing. I did not go to work. I went to a clinic and they tested for Covid-19 the test was negative. Used compresses on the eyes and medication for cold like symptoms. The symptoms lasted an entire week. The cough hung around for three weeks after vaccine.

at 1420 pt reports having a runny nose, sweating, feeling hot and having sever lightheadedness. BP=127/85, P=83, T= 99, O2 sat 98%. Appears anxious. Stating "Oh my god. I can't believe I am having a reaction" multiple times. Fanning herself with her vaccine card frequently. Placed in front of a large fan by this RN. Pt states that the wind feels good. has stopped fanning herself. At 1430 reports mild lightheadedness, no sweating and reports she is ready to go . When this RN turned around pt was gone.

Dizziness/light-headed, feeling like I was about to faint started morning after vaccine along with severe neck pain. Possible intermittent fever. Dizziness continued for 2 days. Neck pain improved somewhat but is still bothering me, woke me up at night. Now a week later and my neck still hurts. I called my primary care office on March 3 and they said call 211. That made no sense so I asked again and they finally said I could see a nurse practitioner the next day. However I didn?t go because I couldn?t drive. I am a little worried about the second dose.

Pain and weakness in my right arm. Inability to lift things above shoulder height. Pain when trying to sleep at night. Pain when trying to do certain things at my job with my right arm.

Pfizer injection Jan 26, 2021 First symptoms 4-5 days after: "unsettled" feelings, disturbed sleep, general "dumpiness" ~9 days after: Tender joints in toes, leg pain and weakness, dry, irritated, blurry eyes, brain issues: dizzy, word retrieval issues, derealizing Feb 11: fatigue, muscle weakness and pain in legs Feg 12: headache, heavy feeling in chest, continuing leg pain and weakness. March 12 Pain in legs persists, but improved, brain issues improving, but not resolved, eyes still somewhat dry and blurry/strained

Woke at 32hrs with severe pain in Rt hip joint and Rt knee joint. later in day rt leg was numb, unable to bear weight, go up stairs without assist or sleep. Next day #3, severe pain in Rt hip, Rt knee and femur. Not responding to Motrin 800mg Q6-8hrs, Tylenol 1gm Q6-8 hours. Day #4 pain now radiating down rt leg through both joints and into Rt calf. Now Monday- called PCP, advised symptoms and would be starting perocets for 2 days of severe pain post vaccine. Also took ASA 325mg for blood clot risk know with virus even through pain was hip to ankle now (not ascending but descending) Percocet Q6hours without improvement but could sit and sleep with pain (dulled brain response to pain). Day #5- leg completely numb, pain now following sciatic nerve, stopped meds as no improvement and developed headaches, stomach aches and constipation from meds. Day#6 Pain severe in am, from hip to ankle- leg and heal of Rt foot numb. Today #7 pain on awaking, Rt hip all along sciatic nerve to foot which remains numb in heel.

Within 5 minutes of injection my eyes begin burning, my head started swimming and I could not focus my vision ,my heart was racing. I had no breathing issues and was able to get through it as it only lasted 6 to 7 minutes. But I'm very concerned as to taking the second dose? Please advise as to getting second dose

When driving home following 15 minute wait period I felt my throat tighten, ears flush and heart rate increasing. I immediately began to monitor my heart rate with my Watch. My resting heart rate is in the 60?s. At the time I looked at the watch my heart rate was already in the low 100?s but was rapidly escalating until in a matter of a few minutes had reached 140 bpm and my head began to have a full sensation and I was becoming very shaky. I pulled over into the parking lot of a restaurant and asked them to call 911. As they were talking with the dispatch my pulse started to decline so I cancelled the request. I stayed at the restaurant until friends to could come pick me up. By the time they arrived my pulse was in the low 100?s. I took 2 Benadryl. I monitored my BP through the night and it did not return to the 60?s until 1:00 am. I took (2) 25 mg Benadryl at approximately 4:00 pm, took another 2 at around 9:00 pm when my heart rate started to escalate and then a final 2 before going to bed at 1:00 am. My pulse dropped back into the 60?s while I was sleeping and stayed that way through the night. I woke up with no further symptoms nor side effects from the shot. The throat tightness and flushing of the ears resolved after the first dose of Benadryl. I had no adverse reactions or significant side effects from he first dose of Pfizer.

3-9-21 6:40PM 'SHARP PAIN IN CHEST X2MIN'. 'ALSO NAUSEA AND FEELS DRUNK'. NO SOB/DYSPNEA. 7:16PM PLACED IN W/C TAKEN TO MEDIC TENT & PLAACED ON CARDIAC MONITOR: NSR NOTED. 7:25PM STATES 'DECREASED NAUSE AND NO CHEST APIN NOW - STILL FEELS DRUNK'. PT DECLINES JUICE AND CRACKERS - STATES SHE WANTS TO WAIT AND TAKE HER DIABETIC MEDS BEFORE SHE EATS'. 7:30PM 'FEELING BETTER' TO EXIT PER W/C TO BE DRIVEN HOME PER DAUGHTER. 3-12-21 1PM TC: STATES 'NO CHEST PAIN , STILL HAS A LITTLE NAUSEA'.

Report small lump to the left ankle 3 weeks post vaccination, not sure if it is related to the vaccine. States it was not there prior to the vaccine. Treatment: none . Outcome: Does interfere with ADLs. Recommend to follow-up PCP for any concerns.

Within hours mild mental fog and fatigue. Intense fatigue leading to bed rest last four days accompanied by mild mental fog, myalgia, intermittent low grade fever and marked depressed mood. Severe left breast pain and left axilla pain on the third day severe enough to wake from sleep. Lasted about 48 hours.

HEART POUNDING, ANXIETY Narrative: Patient felt heart pounding a few minutes after 1st Pfizer covid vaccine. VS: BP 148/90,P99, PO2 95& at 10:22. Symptoms subsided after 10 minutes. Repeat VS at 10:33 BP 147/89. P 87, PO2 100%. Probably anxiety. Released with instructions to seek care at Ed or PCP if symptoms recur.

Approximately 2 hours post vaccine I noticed my scalp feeling hot, tight, and tingly in the bilateral occipital area. Some neck pain and traveling from neck to scalp. Today is 3/17/21 and the symptoms are still present but somewhat improved over the last week. The sensations are now mostly on the R side. I took Advil 400mg TID for 2 days and also applied a heating pad to the neck and back of head. I saw my PCP today as this is causing me a lot of anxiety, she prescribed Prednisone 40mg daily X 3 days.

patient stated she felt like her blood pressure was going up right after vaccine administration. I took her BP and it was 190/112. She got hot and then cold and shaky. I got her some water and propped her feet up and took her blood pressure 3 or 4 more times over about 20 minutes then we decided to call 911.

Today marks 2 weeks since my shot and my right arm is as sore as it was on day one. It?s primarily in the right bicep I feel like muscle is getting weak. I have iced it and taken Advil and Tylenol. Nothing takes the pain away. Additionally the pain wakes me up from sleep.

Shot was given at 1:12pm, immediately could taste the vaccine in the back of my throat. Went to waiting area for 15 minutes. Left to go home, my face cheeks started to turn red within the next 30 minutes. A couple of hours later my skin was tingling, itching, even inside my ears, around my ankles. Took some Benadryl, knowing that it was an allergic reaction, but it didn't help. Couldn't sleep, felt like my skin was crawling. Around 4 am my skin finally calmed down. Sent a message to my Dr. to let him know what happened. Still some lingering itching the next day. Today is Friday March 19, most everything is back to normal.

post injection: 8 minutes-heart pounding so strong I could hear it, continued for 5 or 6 minutes 8 minutes-slight drop in blood pressure (I've gone as low as 32/18 during a bad reaction so I know this time was a much smaller drop) 13 minutes-stomach pains started, these would continue throughout the night waking me, and lasted approximately 17 hours 30 minutes- sudden feeling of lightness in my body, and that a light had gone on 60 minutes-odd sensations in throat but did not feel swelling, simultaneously at 60 minutes-dizzy the next day, 10 bowel movements until 2 pm

Recieved second Pfizer injection (was Covid symptom free for 5 days) at 10 am. AT 3 am awoke with chills and 102.5 fever, nausea and followed by sweats. This has continued thru 3/23/21, so far. On 3/23/21 fever maintained between 100 & 100.8. Still felt badly. Awoke this am 3/24/21, sweaty but no fever thus far. Feeling better.

Dizziness, disorientation, very bad headache on the top of my head, confusion, problems with concentrating and comprehending, lightheaded, fatigue, sensitivity to light. I had a concussion 5-years ago from a car accident and recovered after one year. The symptoms of my concussion have returned within 30 minutes of receiving the Covid vaccine.

101.5 degree fever, chills, dizziness, tiredness, joint pain (L) leg, feeling unwell, swollen lymph nodes (L) armpit Lasted 24 hrs Slept most of the time treated with Advil

On March 17, 2021 I got a really bad sinus headache and my sinuses began hurting. This headache is still and issue. A few days later I got hot flashes at night and had disturbed sleep. The headache has at times caused ear ringing, but not all the time. March 23 I had chills at night. March 24th, I had chills all day. March 25 I still have the headache and my right arm hurts which is where I have lymphedema.

Nausea, vomiting and diarrhea (2 days) Dizziness and lightheadedness (2 days) Vertigo (has been 10 days and is currently happening) Ringing in the ears Brain fog (5 days) Symptoms are ongoing and have decreased only slightly as of this report

6 days after 1st shot - woke up to severe veritgo (spinning) ,, dizzy,sweating , nauseous, lasted 2 1/2 full days . tingling of hairline and under the eyes, eyes were blurry for two days, starting getting heart palpatations, and blood pressure high and resting heart rate low and other times blood pressure was real low and resting heart rate as high as 125 even at rest not due to exercise... this continued with the heart irregularaties for abour two weeks. . i experienced unusal forgetfulness and couldnt recall things I knew .. i had mild fatigue... 3 weeks later Im about 90 percent but a little sluggish. finally was able to do yoga(bending over ) weights,,walking,etc.

Very sore arm , more than any other vaccine I have ever received. It has been improving less than 24 hour later. I woke with a fever (my feet were especially warm) Body aches, especially my joints. Mild cough I have taken ibuprofen and acetaminophen, which help. This was my second Pfizer dose. Other than a mildly sore arm, I had no issues with the first dose

Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness. After 15 minute observation period pt informed nurse of slight dizziness and thinks its anxiety. She was evaluated by EMS and per EMS is okay to be discharged home. Vitals were WNL and pt was alert, oriented, and ambulatory at discharge. Assessment : Time of assessment 1503. Alert and oriented. Actions taken: Vitals sign taken Vitals WNL Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 15 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat.

Within 15 minutes of receiving the shot, I became extremely dizzy and lightheaded. I also had tingling and pain in the other arm from the wrist up to my neck. The medics took me into a room to lie down for 30 minutes and it seemed to pass. I have felt off and foggy for the past 3 weeks. And now for the past 3 days, I have been feeling the same feeling of lightheadedness and dizziness that I had after the shot throughout every day. I am sure this is related to the vaccine. I never had anything like this in my life. I did not take the second shot and still feel awful. I have spoken to people who had the same immediate allergic reaction.

Approximately 5 mins after receiving the 2nd dose of Pfizer COVID-19, patient reported she begin to feel faint and dizzy. She also reported feeling nausea. Patient was alter and oriented, no difficulty breathing. Vitals were taken, patient's O2 was 98, pulse 56, and BP 90 by palpitation. Second BP taken 5 minutes later, BP raised to 118 by palpitation. Patient sipped on water, was laid back in the car, and windows rolled down. Patient reported she mitral valve prolapse and when she gets anxious, she starts to feel faint. Patient continued to be alert and oriented and within 15 minutes after first feeling faint, she stated she was feeling better. Was able to walk from driver to the passenger side of the car, patient reported she felt better and vitals were normal.

3-25-21 3:36PM PT 'FEELS SOB, ANXIOUS, CHEST TIGHT' . PT IS EXTREMELY ANXIOUS. STATES IT IS THE FIRST TIME SHE HAS BEEN OUT OF HER HOME IN OVER A YEAR. WATER, BATTERY OPERATED FAN AND COMFORT GIVEN. A/O, PINK, W/D. 3:48PM PT STATES 'FEELING A LITTLE BETTER'. 4:13PM TO EXIT WITH SON TO BE DRIVEN HOME. NO ACUTE DISTRESS. GAIT BRISK AND STEADY.

I have tinnitus...so loud I can not get away from it. I noticed it when I went to sleep last night. I had the shot at 3Pm Saturday. I woke up at 3:47 and started to feel terrible. Chills, severe congestion, head hurt so bad, nauseous, ached all over. I have never felt so badly EVER. at 3pm Sunday I took two tylenol and everything got better. I was fatigued but functioning. I still had a slight headache but was able to eat a light dinner. Monday I was so fatigued I could not drive or go to work. I had severe brain fog. Monday night I noticed how loud my ears were when I went to bed. I could not get away from the noise. today the brain fog seems to be lifting but I am still drained and not feeling great. no energy. I have heart palpitations and shortness of breath. At one point I had a pain in my chest and was concerned about a blood clot. That seems to have passed the palpiations remain.

Patient was anxious before the shot was given. She was given orange juice and water to hydrate her just in case. After the shot she passed out and was disoriented and nauseated when she came out. Paramedics were called for evaluation and they took her to the hospital due to continued weakness and vomiting.

Starting that afternoon I was sore all over and very tired, foggy and nauseous for 2 days. Those symptoms continued for 2 weeks except the nausea. About 3 days in I lost taste and smell for 1 day. The loss of taste came and went for maybe 1 month. Sometimes now, I still have a loss of taste with certain foods and others do not taste like they used to taste.

1 day after, low grade fever/unsettled stomach/chills/dazed/fatigue 4 days after dizzy enough to hold onto walls/headache/red & sore eyes watery/debilitating 5-7 days dizziness has decreased, not debilitating but still there when bending over, looking up, moving fast, unsettled stomach decreased but comes in waves still happening

5 minutes after injection, fogginess and sleepy. Sort of like being drunk. Did not want to talk. Lethargy and weakness. High BP. This was a much shorter time than after 1st one. Next day: left arm/hand/fingers had uncontrollable muscle movements, beginning about 9:30 am.

At work suddenly became dizzy drunk feeling with I went on FLMA. nausea. Unsteady on my feet. felt as if my heart was vibrating. I am sure later I had a TIA. Was unable to communicate. I knew what I wanted to say but I could not get the words out. March 1/2021 I went on FLMA. It never dawned on me the vaccine could have affected my already stressed heart. I am still experiencing these symptoms. I just thought of this this week. I still have extreme fatigue, increased palpitations, and increased SOB. I do not feel able to work right now.